BO Y TIE CUC AN I OAN THUG PHAM - An toàn thực phẩm · 2020-03-12 · COINC IK)A XA HOI C HU...
Transcript of BO Y TIE CUC AN I OAN THUG PHAM - An toàn thực phẩm · 2020-03-12 · COINC IK)A XA HOI C HU...
COINC IK)A XA HOI C HU NGHIA VIF I NAM Doc lap - I n do - Hanh phuc
BO Y TIECUC AN I OAN THUG PHAM
Sd^^'KL-ATTP Ha Npi, ngayjAthansflJncwn 2020
KET LUAN THANH TRA> • A y r r\ A y AVe vice thanh tra vice chap hanh phap In at vc an loan thne pliam trong san xuat, kinh doanh, nhap khan, qnang cao thne pham
bao ve she khoe tai tinh Ben Ti e va Tien Ciang
Thirc hien Quyet dinh thanh tra so 1006/QD-ATTP nga> 11/1 1/2019 cua
Cue truong Cue An loan thire pham ve vice thanh tra vice ehap hanh eae c]u\ dinh phap luat trong san xuat. kinh doanh. nhap khau. quang eao san pham llurc
pham bao ve sue khoe tren dja ban tmh Ben Ire va lien (iiang. tu nga\ 19/1 1/2019 den 10/01/2020, Doan thanh tra da tien hanh thanh tra tai 02 eo- so' tai tinh Ben Ire va 03 co so tai tinh Tien (iiang (gbm thdi gian thanh tra tai eo
so. kiem tra xac minh ho so1 eua eo so dupe thanh tra tai tru so eo' quan. kiem
nghiem 13 man lay tai eo so dupe thanh tra, thdi gian Chi eue An Loan ve sinh
thue pham Ben Tre xae minh hang hda \ i pham. ban hanh Quyet dinh \u phat \ i pham hanh ehinh ddi vdi eo so vi pham).
Xet bao cao ket qua thanh tra nga> 30/01/2020 eua I nrong doan thanh
tra. y kien giai trinh cua ddi tirpng thanh tra. Cue tru’dng Cue An loan thue pham
ket luan nhir sau:
I. Khai quat dac diem tinh hinh to clnVc, boat dong cd lien quan den
npi dung thanh tra ciia 05 co' so la ddi tupng thanh tra
1. Cong ty TNHH Mot thanh vien Hien Hai Phat, dja chi: So 691/1, dudngsd 1, khu Phd My Tan, phudng 7, thanh phd Ben Tre, tmh Ben I re
Gidy ehiing nhan dang ky doanh nghiep Ma so doanh nghiep: 1300986642, dang ky lan dau ngay 29 thang 05 nam 2015. dang ky tha\ ddi lan
thir 1. ngay 25/12/2015 do Phong Dang ky kinh doanh eua So Ke hoach va Dau
tu tinh Ben I re cap.
l ong so san pham thue pham bao vc sue khoe do eo so cong bd tai Cue
An loan thue pham: 12 hd so edng bd eon hieu lire.
2. Cong ty cd phan Sa Sam Viet, dja chi: So 430C1 NguytMi Hue, Phudng Phti Khuong, thanh phd Bimi Tre, tinh Ben Tre
Giay ehung nhan dang ky doanh nghiep Ma so doanh nghiep: 1301015435, dang ky lan dau ngay 06 thang 09 nam 2016. dang ky lha\ ddi lan
tlur 5. ngay 22/07/2019 do Phong Dang ky kinh doanh ciia So Kc hoach \a Dau
tir tinh Ben Tre cap.
l ong so san pham tlurc pham hao ve sire khde eo so eong ho san pham: 08 san pham ho so eong bo con hieu lire.
3. Cong ty Co phan Dime pham TIPHARCO, dja chi: Ld 08 - 09 C um
Cong Nghiep va Ticu thii Cong Nghiep I an My Chanh, Phudng 9, Ihanh phd My Tho, tinh Tien Giang.
Giay chirng nhan dang ky doanh nghiep eong ty eo phan so 1200100557
dang ky lan dau ngay 28/02/2006. Dang ky tha> doi lan thir 14 nga\ 27/04 2018 do Phong Dang ky kinh doanh ciia So Ke hoach va Dau tir tinh Tien Ciiang cap.
Tong so san pham tlurc pham bao ve sire khoe do eo' so' eong bo tai Cue An loan tlurc pham: 20 san pham ho so- eong ho eon hieu lire.
4. Cong ty Co phan Thien Nhien Viet, ilia chi tru so chinh: So 1 15 Qudc lo 50, Ap Phong Thuan, Xa Tan My Chanh, thanh phd My I ho, tinh Tien Giang. Dja chi Chi nluinh Cong ty - noi dang k\ co so san
xuat: Ap Long Hda, Xa Dao I hanh, I hanh phd My I ho, I ien (»iang
Giay chirng nhan dang ky doanh nghiep eong t) eo phan so 1200725654
dang ky lan dau ngay 31/07/2008. Dang ky thay doi lan thir 10 ngay 07/10/2014
do Phong Dang ky kinh doanh - So Ke hoach va Dau tir tinh Tien Giang cap.
Tong so san pham tlurc pham bao ve sire khoe do eo so eong bd tai Cue
An loan tlurc pham: 13 san pham ho so eong bd con hieu lire.r r
5. Co' so san xuat Dong Nam Dime Ngoc Lien, dja chi: 127/9 Le I hi Hong Gam, Phudng 6, thanh Phd My Tho, tinh T ien Ciiang
Giay chirng nhan dang ky hd kinh doanh so 53A8022429 dang k\ lan dau
ngay 12/08/2011. Dang ky thay doi lan thir 02 nga\ 1 1 6 2018 do Phong Tai chinh - Ke hoach thude Uy ban nhan dan I hanh phd M\ 1 ho cap.
Tong so san pham tlurc pham chtrc nang/ tlurc pham bao \e sire khoe eo so eong bd: 09 san pham hd so edng bd con hieu lire.
r v
II. Ket qua kiem tra, xac minh
1. Cong ty TNHH Mot thanh vien HiC‘n llai Phat, dja chi: SO 69L1, dudng so 1, khu Phd My Tan, phudng 7, thanh phd Ben Tre, tinh Ben I re
(1) Cong hd san pham:
Tai thdi diem thanh tra, Giam doe Cong ty bao eao. Cong l\ edng bd 12
san pham tlurc pham bao ve sire khoe. cac hd so1 edng bd eon hieu lire, eu the:
- Tlurc pham bao ve sire khoe Sim PF.PT1NF-H. Giay xac nhan cong bo
plui hop quy dinh an loan tlurc pham so 10163/2017/ATTP-XNCR ngav
05/4/2017.
- Tlurc pham bao ve sire khoe BEST GLUCO-ll, Gia\ xae nhan eong bo
phu hop quy dinh an loan tlurc pham so 10164/2017/A 1 I P-XNCB nga\ 05/4/2017.
- Thire pham bao ve sire khoe GOOD BRAIN-H. Giay xae nhan eong bo
phu hop quy dinh an loan thire pham so 10162/2017/ATTP-XNCB nga\ 05/4/2017.
- Thire pham bao ve sire khoe dai trang GOOD -11, Giay xae nhan eong bo phu hop quy dinh an loan thire pham so 10159/2017/ATTP-XNCB ngav
05/4/2017.
- Thire pham bao ve sire khoe Vien xuong khop khuan Hoa - IT Gia\ xae nhan eong bo phu hop quy dinh an loan thire pham so 10161/2017 A 1 1 P- XNCB ngav 05/4/2017.
- 'Thire pham bao ve sire khoe CURMIN GOI D. Gifo tiep nhan dang k\ ban eong b6 s6 2147/2018/DKSP ngav 02/5/2018.
- Thire pham bao ve sue khoe 1TEMO VEIN 11 NHAt TAM. Gia\ tiep
nhan dang ky ban eong bo so 2746/2018/DKSP ngav 21/5/2018.
- Thire pham bao ve sue khoe Calmax Pluss Nhat Tam. Giay tiep nhan
dang ky ban eong bo so 4290/201 8/DKSP ngay 1 2/7/201 8.
- Thire pham bao ve sue khoe Giai doe gan T-l T Giay tiep nhan dang k\ ban eong bo so 11875/2019/DKSP ngay 18/10/2019.
- Thire pham bao ve sue khoe SIRO EUC VI T-H. Giay tiep nhan dang ky ban eong b6 s6 1 1982/2019/DKSP ngay 22/10/2019.
- Mure pham bao ve sue khoe Sim Nhan Phue. Giay tiep nhan dang k\ ban eong b6 s6 1 1 874/2019/DKSP ngay 18/10/2019.
- Thire pham bao ve sue khoe Sim Yen Sao THYMO MK7 -I T Gia> tiep
nhan dang ky ban cong b6 s6 11873/2019/DKSP ngay ] 8/10/2019.
(2). Ghi nhan san pham: Doan lhanh tra danh gia ve ghi nhan eua 08
san pham tai kho Cong ty ghi nhan:
2.1 So san pham dirge kiem tra ve ghi nhan: 08 san pham
2.2 So san pham co nhan ghi dung qu\ dinh: 06 san pham
2.3 So san pham eo nhan ghi khong dung qu\ djnh: 02 san pham
Cu the:
- 02 san pham nhan khong phu hop voi eong bo la:
-I- Thuc pham bao ve sue khoe MEMO VEIN
010618, NSX 16/6/18, USD: 15/06/21: Noi dung ghi nhan khong plui hap \ ai nhan do Cong ty TNHH Mot thanh vien Hien Hai Phat cong ho diroc Cue An
loan llurc pham cap Giay tiep nhan dang kv ban cong bo so 2746/2018/DKSP
ngay 21/5/2018.
11 NI1A I PAM. 16 SX:
+ Thuc pham bao ve sire khoe Calmax Pluss Nhat l am. 16 SX: 180633. NSX 16/08/18. USD: 15/08/21: Noi dung ghi nhan khong phu hop voi nhan do
Cong ty TNI 111 Mot thanh vien I lien Hai Phat cong bo diroc Cue An loan llurc
pham cap Giay tiep nhan dang ky ban cong bo so 4290/2018/DKSP nga\ 12/7/2018.
- 06 san pham nhan phu hop voi cong bo la:
i Thirc pham bao ve sire khoe CURM1N GOED. 16 SX: 180458. NSX
26/05/18, USD: 25/05/21: Noi dung ghi nhan phu hop voi nhan do Cong ty
TNI 111 Mol thanh vien I lien Hai Phat cong bo diroc Cue An loan thirc pham cap
GiAy ti6p nhan dang ky ban cong b6 s6 2147/2018/DKSP ngay 02/5/2018.
+ Thirc pham bao ve sue khoe dai trang GOOD -El. 16 SX: 190154. NSX
16/03/19. USD: 15/03/22: Noi dung ghi nhan phu hop voi nhan do Cong t\ TNHH Mol thanh vien Mien Hai Phai cong bo diroc Cue An loan llurc pham capGiay xac nhan cong bo phu hop quy dinh an loan llurc pham so10159/2017/ATTP-XNCB ngay 05/4/2017.
+ Thirc pham bao ve sire khoe Siro PEP11NE-E1. 16 SX: 190133. NSX
18/03/19. USD: 17/03/22: Noi dung ghi nhan phu hop voi nhan do Cong l\ TNHE1 Mot thanh vien Mien Hai Phat cong bo diroc Cue An loan llurc pham cap
Gidy xac nhan cong bo phu hop qii)' dinh an loan thirc pham so10163/2017/ATTP-XNCB ngay 05/4/2017.
-i Thirc pham bao ve sue khoe BEST GE11CO-H. 16 SX: 180712. NSX
25/10/18. USD: 24/10/21: Noi dung ghi nhan phu hop voi nhan do Cong tv
T NHH Mol thanh vien Hien Hai Phat cong bo dupe Cue An loan llurc pham cap
Gmy xac nhan cong bo phu hop quy dinh an loan thirc pham so10164/2017/ATTP-XNCB ngay 05/4/2017.
i Thuc pham bao ve sue khoe Vien xirong khop Thuan 1 loa
180412, NSX 27/06/2019, USD: 26/06/2022: Noi dung ghi nhan phu hop voi nhan do Cong ty TNITH Mol thanh vien Hien Hai Phat cong bo dupe Cue An
loan thirc pham cap Giay xac nhan cong bo phu hop quy dinh an loan llurc pham
s6 10161/201 7/ATTP-XNCB ngay 05/4/201 7.
+ Thuc pham bao ve sue khoe GOOD BRA1N-H. 16 SX: 190516. NSX
29/06/19, USD: 28/06/22: Npi dung ghi nhan phu hop voi nhan do Cong ty
TNHH Mot thanh vien I licm Hai Phat cong bo dupe Cue An loan (hue pham cap
II. 16 SX:
Giay xac nhan cong bo phu hap qii_\ dinh an loan ihirc pham so
10162/2017/ATTP-XNCB ngay 05/4/2017.X V(3) . Dieu kien bao dam an toan thuc pham
Dieu kien kho bao quan cua Cong ty co ban dap irng dieu kien bao quan san pham thuc pham.
(4) . Quang cao san pham:
I heo bao cao cua Giam doc Cong tv. Cong ty khong co website. Cong indirge Cue An toan thuc pham cap Gia\ xac nhan ngi dung quang cao so
01457/201 8/ATTP-XNQC ngay 06/12/2018 cho san pham thuc pham bao ve
sue khoe MEMO VEIN II NHAT TAM. Tai thai diem thanh tra. Cong i\khong quang cao thuc pham bao ve sue khoe.
(5). Lay man kiem nghiem: Doan thanh tra lay man 07 san pham thuc
pham bao ve sue khoe. Ket qua kiem nghiem 07/07 man dal yen can (phieu
kiem nghiem s6 028089; 028090; 028091; 028092; 028093; 028094; 028095/PNK-YTCC ngay 18/12/2019 cua Vien Y lC; cong cong Thanh phb Mb
Chi Minh).
2. Cong ty co phan Sa Sam Viet, dia chi: So 430CI Nguyen Hue, Phuong Phu Khirong, thanh phb Ben I re, tinh Ben I re
(1) Ho so hanh chinli, phap ly ciia co so:
Giay chung nhan co so- dii dieu kien an loan ihuc so 000465/201 8 A 1 1 P- CNDK. ngay 01/8/2018 do Cue An toan thuc pham cap
(2) . Cong bo san pham:Tai thoi diem thanh tra. Giam doc Cong ly bao cao. Cong i\ cong bo 08
san pham thuc pham bao ve sue khoe. cac ho so- cong ho con hieu lire, cu ihe:
- Thuc pham bao ve sue khoe BeaulySAM. Giay tiep nhan dang kv ban
cong b6 s6 6375/2019/DKSP ngay 05/6/2019.
- Thuc pham bao ve sue khoe SulinSAM. Gia\ liep nhan dang k\ ban
cong bb sb 5659/2019/DKSP ngay 22/5/2019.
- I huc pham bao ve sue khoe LiverSAM. Gia_\ liep nhan dang k} ban
cong bb so 5661/2019/DKSP ngay 22 5/2019.
- Thuc pham bao ve sue khoe NeuroSAM. Giay tiep nhan dang k\ ban
cong bb sb 5660/2019/DKSP ngay 22/5/2019.
- Thuc pham bao ve sue khoe ColoSAM. Gia\ liep nhan dang ky ban
cong bb sb 5662/2019/DKSP ngay 22/5/2019.
- Thuc pham bao ve sue khoe PowerSAM. Giay tiep nhan dang ky ban
cong bb sb 6442/2019/DKSP ngay 05/6/2019.
- Tlurc pham bao ve sire khoe Bo.loSAM. (iia\ liep nlian dang k\ ban
cong bb sb 5658/2019/DKSP ngay 22/5/2019.
- Thuc pham bao ve sire khoe BronSAM, Gia\ liep nhan dang k\ ban
ebng bb sb 5663/2019/DKSP ngay 22/5/2019.
(3). Ghi nhan san pham: Doan thanh Ira danh gia ve ghi nhan eua 08
san pham tai kho Cong ty ghi nhan:
3.1 Sb san pham dirge kiem Ira ve ghi nhan: 08 san pham
3.2 Sb san pham co nhan ghi dung quy dinh: 08 san pham
3.3 Sb san pham co nhan ghi khbng dung qu_\ dinh: 0 san pham
Cu the 08 san pham nhan phu hop voi ebng bb la:
- Thuc pham bao ve sire khoe BeaulySAM. lb SX: 320519. NSX 090619. USD: 090622: Nbi dung ghi nhan phu hop voi nhan do Cong l> eb phan Sa
Sam Viet ebng bb dirge Cue An loan thire pham eap (iia_\ liep nhan dang k\ ban ebng bb sb 6375/2019/DKSP ngay 05/6/2019.
- Thire pham bao ve sire khoe SulinSAM. lb SX: 040619. NSX 020619. HSD: 020622: Nbi dung ghi nhan phu hop voi nhan do Cong is eb phan Sa
Sam Viet ebng bb dirge Cue An loan thire pham eap (lias liep nhan dang k\ ban ebng bb sb 5659/2019/DKSP ngas 22/5/2019.
- Thuc pham bao ve sire khoe LiverSAM. lb SX: 300519. NSX 300519. HSD: 300522: Nbi dung ghi nhan phu hop voi nhan do Cong ty eb phan Sa
Sam Viet ebng bb dirge Cue An loan thire pham eap Giay liep nhan dang k\ ban ebng bb sb 5661 /2019/DKSP ngas 22 5 2019.
- Tlurc pham bao ve sire khoe NeuroSAM. lb SX: 010619. NSX 310519. HSD: 310522: Nbi dung ghi nhan phu hop sbi nhan do Cong ts eb phan Sa
Sam Viet ebng bb dupe Cue An loan thire pham cap Giay liep nhan dang ks
ban ebng bb sb 5660/2019/DKSP ngay 22/5/2019.
- Thire pham bao ve sue khoe ColoSAM. lb SX: 030619. NSX 010619. HSD: 010622: Nbi dung ghi nhan phu hop sbi nhan do Cong t> eb phan Sa
Sam Viet ebng bb dirge Cue An loan thuc pham cap Giay liep nhan dang ks
ban ebng bb sb 5662/2019/DKSP ngay 22/5/20 19.
- Thire pham bao ve sue khoe PosverSAM. lb SX: 310519. NSX 080619. HSD: 080622: Nbi dung ghi nhan phii hgp vb'i nhan do Cong t> eb phan Sa
Sam Viet ebng bb dirge Cue An loan thire pham cap Gias liep nhan dang ks
ban ebng bb sb 6442/2019/DKSP ngas 05/6/2019.
6
- ['hire pham bao ve sire khoe BoJoSAM, 16 SX: 020619. NSX 310519. USD: 310522: Ngi dung ghi nhan phu hop voi nhan do Cong ty co phan Sa
Sam Viet eong bo dirge Cue An loan tlure pham eap (jia> liep nhan dang k\ ban eong bo s6 5658/2019/DKSP ngay 22/5/2019.
- Tlure pham bao ve sire khoe BronSAM. 16 SX: 290519 01. NSX
020619. HSD: 020622: N6i dung ghi nhan phu hop voi nhan do Cong ty eo
phan Sa Sam Viet eong bo dirge Chav tiep nhan dang ky ban eong ho so
5663/2019/DKSP ngay 22/5/2019.
(4) . Dieu kien bao dam an loan Ihuc pham
Dieu kien kho bao quan cua Cong ty dap irng dieu kien bao quan san
pham tlure pham.
(5) . Quang cao san pham:
T'heo bao eao eua Giam doe Cong ty. Cong ty eo website: sasamx iet.eom. hien nay eong ty dang trong qua trinh hoan thien ho so de giri ve (’tie An loan
tlure pham dang ky xac nhan ngi dung quang eao doi voi eae san pham tlure
pham bao ve sire khoe eua Cong ty. I lien tai Cong ty ehira tlure hien quang eao
tlure pham bao ve sire khoe.
Tai thoi diem thanh Ira. Doan lhanh tra ghi nhan website: sasann iet.eom
khong quang eao eae san pham tlure pham bao \e sire khoe eua Cong t\.
(6) . Lay man kiem nghiem: Doan thanh tra lay man 03 san pham tlure
pham bao ve sire khoe. Ket qua kiem nghiem 03/03 man dal yen eau (phieu
kiem nghiem s6 028096; 028097: 028098/PNK-YTCC nga\ 18/12/2019 eua
Vien Y te eong eong Thanh pho 116 Chi Minh).
3. Cong ty Co phan Duoc pham Tll’HARCO, dja chi: L6 08 - 09 Cum
Cong Nghicp va Tien thii Cong Nghiep Tan My Chanh, Phuong 9, thanh
pho My Tho, tinh Tien Giang.
(1) . Ho so hanh chlnh, phap ly ciia eo so:
Gia\ elurng nhan eo so du dieu kien an loan tlure pham so: 46/2019/ATTP-CNOMP ngay 17/7/2019 do Cue An loan thire pham eap Dal yen eau Tlure hanh san xuat tot (GMP) thire pham bao ve sire khoe.
(2) . Cong bo san pham:
Tai thoi diem thanh tra, Cong ty Co phan Dirge pham NPllARCO bao
eao: Cong ty eong bo 20 ho so1 con hien lire, trong do 1 2 san pham dang san xuat va kinh doanh. 08 san pham dura dira vao san xuat (Bao eao so
7
946/BC.71PHARCO ngay 20/11/2019 cua Cong ty Co phan Dupe pham
T1PHARCO kern theo).
(3) . Ghi nhan san pham: Doan thanh tra danh gia ve ghi nhan cua 06 san
pham tai kho Cong ty ghi nhan:
3.1 So san pham dirge kiem tra ve ghi nhan: 06 san pham
3.2 So san pham co nhan ghi dung quy dinh: 06 san pham
3.3 So san pham co nhan ghi khong dung quv dinh: 0 san pham
Cu the 06 san pham nhan phu hop voi cong ho la:
+ Thirc pham bao ve sue khoe Ira Gung kipha. 16 SX: 050519. NSX
02.05.19. BSD: 02.05.22: Npi dung ghi nhan phu hop voi nhan do Cong ty Co phan Dirge pham TIPHARCO eong ho dupe Cue An loan thire pham cap Ciiay
tiep nhan dang ky ban eong ho so 85 14 201 8/DKSP nga\ 24 10 20 I 8.
i I hue pham hao ve sue khoe I ra Chum Ngay. 16 SX: 021019. NSX22.10.19. USD: 22.10.21: Npi dung ghi nhan phu hop voi nhan do Cong tv C 6
phan Dupe pham I IPHARCO eong bo dirge Cue An loan thue pham cap Giay
tiep nhan dang ky ban eong b6 so 8512/2018/DKSP nga\ 24/10/2018.
+ Thue pham bao ve sue khoe Vien ngam Kueagitan. 16 SX: 010718. NSX
31.07.18, USD: 31.07.20: Npi dung ghi nhan phu hop voi nhan do Cong l\ Co
phan Dupe pham TIPHARCO eong bo dupe Cue An loan thue pham cap Gia) xac nhan eong bo phu hop quy dinh an loan thue pham so 47908/201 7/A 1 I P- XNCB ngay 19/12/2017.
+ Thue pham bao ve sue khoe Duong nao Tipha. 16 SX: 010818. NSX
27.08.18. HSD: 27.08.21: Npi dung ghi nhan phu hop voi nhan do Cong tv Co
phan Dirge pham TIPHARCO eong bo dirge Cue An Loan thue pham cap Gia) xac nhan eong bo phu hop quy dinh an loan thue pham so 8765/2017 A I TP- XNCB ngay 26/3/2017.
i Thue pham bao ve sue khoe Tra Thanh Nhiet kipha. 16 SX: 010319. NSX 03.03.19. HSD: 03.03.21: Npi dung ghi nhan phu hop voi nhan do Cong t) Co phan Dupe pham TIPHARCO eong bo dupe Cue An loan thue pham cap
Giay tiep nhan dang ky ban eong bo so 8513/201 8/DKSP ngay 24/10/201 8.
i Thue pham bao ve sue khoe Sim Ho kuca. 16 SX: 041010. NSX23.10.19, HSD: 23.10.21: Npi dung ghi nhan phu hop voi nhan do Cong i\ CO
phan Dupe pham TIPHARCO eong bo dirge Cue An loan thue pham cap Gia\ xac nhan eong bo phu hop quy dinh an loan thue pham so 35686/2016/ATTP-
XNCB ngay 21/12/2016.
(4) i)ieu kien bao dam an loan thue pham
Cong tv dirge Cue An loan thire pham eap Ciiay ehirng nhan eo1 so' du dieu
kien an loan thire pham dal yen eau Thire hanh san xual tot (GMP) thire pham
bao ve sire khoe so: 46/2019/ATTP-CNGMP ngay 17/7/2019 eae dang san pham sau: Vien nen. vien nen bao phim. vien nen bao dirbng. vien nang eirng. ebm. bot. vien nang siii. com sui. bot siii. siro. dung dich. tra boa tan. tra tui loe.
Tai thdi diem thanh tra ghi nhan Cong ly duy tri dieu kien an loan thire
pham dal yen eau Thire hanh san xual tot (GMP) thire pham bao ve sire khoe theo quy dinh; kho bao quan dap irng dieu kien bao quan thire pham: eo khu \ ire
liru man va thire hien liru man theo quy dinh: danh gia eae dieu kien bao dam an
loan thire pham khac phu hop theo tir danh gia va bao cao eiia Cong t\ Co phan Dirge pham 11PHARCO tai Bao cao so 946 BC. 1IP1 IARC() nga\ 20 1 1 2019.
(5). Quang cao san pham:
Theo bao eao eua Cong ty Co phan Dirge pham 11P11ARCO. Cong tv eo
website: tipharco.com.vn, Cong ty dirge Cue An loan thire pham cap 02 Gia\ xae nhan ngi dung quang eao eon hieu lire.
Tai thdi diem thanh tra. Doan thanh tra ghi nhan:
- Cong ty quang eao dang to roi. noi dung 02 to roi quang eao 02 thire
pham bao ve sue khoe phu hop vdi noi dung da dirge Cue An loan thire pham
xae nhan gom:
i [hire pham bao ve sue khoe Siro 1 lo Euea (Giay xae nhan eong bo phu
hgp quy dinh an loan thire pham so 35686/2016/AT I'P-XNCB) phu hgp vdi Giay xae nhan ngi dung quang eao so 00504/2017/AT IP-XNOC ngav
04/4/2017.
i Phire pham bao ve sue khoe Gbi earn cum hoa cue (Gia) xae nhan cbng
bo phu hop quy dinh an loan thire pham so 1065/2017/A 1 1 P-XNCB) phu hop
vdi Giay xae nhan noi dung quang eao so 00983/2017/A 1 1 P-XNGC ngav
19/6/2017.
- Website: tipharco.com.vn khdng quang eao eae san pham thire pham bao
ve sue khoe eua Cong ty.
(6). Lay man kiem nghiem: Doan thanh tra lay 03 man san pham thire
pham bao ve sue khoe. Ket qua kiem nghiem 03/03 man dat you eau (phieu
kidm nghiem sd 028099; 028100: 028109/PNK-Y TCC ngav 18/12/2019 eua
Vien Y te eong eong Thanh phd 116 Chi Minh).
4. Cong ty Co phan Thien Nhien Viet, dia chi tru so ehinh: So 1 15
Qnoc lo 50, Ap Phong Tinian, Xa I an My Chanh, thanh phd My I ho, tinh l ien (Gang
(I). 116 so hanh ehinh, phap ly ciia co so:
9
Giay chirng nhan ca sa du dieu kien an loan tlurc pham so: 001620/20! 7/ATTP-CNDK nga\ 21/12/2017 do Cue An loan dure phum cap
eho Chi nhanh Cong ty co phan Thien Nhien Viol, dia chi: Ap Long 116a. Xa Dao Thanh. Thanh pho My Tho. l ien Chang.
(2). Cong bo san pham:
Tai thai diem thanh tra. Cong ty co phan Thien Nhien Viet hao cao: Cong
tv cong bo 13 ho so con hieu lire, eu the:
- Thirc pham hao ve sire khoe VILN NGAM GU’NG VI1TNAT '' khong
du'ong do Cong ty co phan Thien Nhien Viet cong bo dirge Cue An loan thirc
pham cap Giay tiep nhan dang ky ban cong bo so 8247/2018 1 )KSP nga\ 16/10/2018.
- Thirc pham bao ve sire khoe Vien ngam COXII L.X 1 KA (iG'NCi Coxil Extra Ginger Lozenge do Cong t\ co phan Thien Nhien Viet eong bo duue Cik
An loan thirc pham cap Giay tiep nhan dang ky ban cong bo so
8402/2018/DKSP ngay 22/10/2018.
- Thuc pham bao ve sire khoe Vien ngam COXIL EXTRA Coxil Extra
Cough Lozenge do Cong ty co phan Thien Nhien Viet cong bo dirge Cue An loan thirc pham cap Giay tiep nhan dang k\ ban eong bo so 9771 CO 1 8 DKSP
ngay 04/12/2018.
- Thirc pham bao ve sire khoe Vien ngam COXIL EX TRA khong dirong
Coxil Extra Cough Lozenge Sugar Free do Cong t\ co phan Thie-n Nhien
Viet cong bo dirge Cue An loan thirc pham cap Giay tiep nhan dang k\ ban eong
b6 so 9772/2018/DK.SP ngay 04/12/2018.
- Thirc pham bao ve sire khoe Vien ngam VIACOl K do Cong tx co phan
Thien Nhien Viet cong bo dirge Cue An loan thirc pham cap Gia\ tiep nhan
dang ky ban cong b6 s6 10268/2018/DKSP nga> 1 7/12/201 8.
- Thirc pham bao ve sue khoe Siro COXIL (S1RO COXIL Coxil Natural Cough Relief Syrup) do Cong ty co phan Thien Nhien Viet eong bo dirge Cue
An loan thirc pham cap Giay tiep nhan dang ky ban eong bo so
10269/2018/DK.SP ngay 17/12/2018.
- Thirc pham bao ve sue khoe Vien ngam Viasol One do Cong t\ eo phan
Thien Nhien Viet cong bo dirge Cue An loan thirc pham cap Giay tiep nhan
dang ky ban cong bo so 10553/201 8/DKSP nga\ 26/12 20 I 8.
- Thirc pham bao ve sue khoe VIEN NGAM Viasol HUNG C11ANTI do
Cong ty co phdn Thien Nhien Viet cong bo dirge Cue An loan thirc pham cap
Giay tiep nhan dang ky ban cong bo so 5179/2019/DKSP ngay 1 5 05 201 9.
10
- Tlurc pham bao ve sire khoe VietNat" KEO GU'NG GINGER do Cong
ly co phan Thien Nhien Viel cong bo dirge Cue An loan tlurc pham cap Gia\ tiep nhan dang ky ban eong bo so 5178/2019/DK.SP ngay 1 5/05/2019.
- Thirc pham bao ve sire khoe Viaiux i' extra do Cong ly eb phan Ihien
Nhien Viel eong bo dirge Cue An loan thire pham cap Gia\ liep nhan dang k\ ban eong bb s6 6959/2019/DKSP ngay 12/06/2019.
- Thirc pham bao ve sire khoe VialuxT exlra khong duong do Cong l\ eb phan Thien Nhien Viel eong bb dirge Cue An loan thirc pham cap Gia\ tiep
nhan dang ky ban eong bb so 6960/2019/DKSP ngay 12/6/2019.
- Thire pham bao ve sire khoe VII'N NGAM MIAO MOC Ihien Nhien
Viet do Cong ly eb phan Thien Nhien Viet eong bb dirge Cue An loan thire
pham cap Giay tiep nhan dang ky ban eong bb so 7895/2019 DkSP nga\ 25/6/2019.
- Thire pham bao ve sire khoe Viacol Plus do Cong t\ eb phan Thien
Nhien Viel eong bb dirge Cue An loan thire pham cap Giay xac nhan eong bb
phu hop quy djnh an loan thire pham so 3953/2017'ATTP-XNCB nga\ 03/02/2017.
Tai thbi diem thanh Ira. theo bao eao eua Cong ly. Cong ly dang lam
ngirng san xuat eae san pham neu Iren, ehb xa\ dung nha ma> dal GMP mbi san
xuat tiep. l ong so san pham eo so da san xuat: 08 (Viaeok Viatux Exlra khong
duong. Viatux Extra, Girng Vietnat khong duong. Siro 1 ae Viatux. Viasol hung
chanh, Viacol plus. Gung Vietnat. Viasol que). Cae mat hang nay eong tv da san
xuat triroc ngay 01/07/2019 va da xuat ban bet. hien tai khong eon ton kho.
(3) . Chi nhan san pham: Doan thanh tra khong danh gia
(4) . Dieu kien bao dam an toan thirc pham
Doan thanh tra ghi nhan theo bao eao eua Cong ly: Triroc nga_\ 01/07/2019, Cong ly san xuat thire pham bao ve sire khoe tai Chi nhanh Cong t>
Cb phan Thien Nhien Viet, dia chi: Qubc lb 50. ap I ong Mba. xa Dao I hanh. TP. My Tho, tinh Tien Giang theo Giay ehirng nhan eb so du dieu kien an loan
thire pham so 001620/2017/ATTP-CNDK ngay 21/12/2017 do Cue An Loan
thirc pham cap. Tir ngay 01/07/2019 den nay. Cong ty da ngirng san xuat thire
pham bao ve sue khoe do eo so tai Chi nhanh Cong t\ Cb phan I hien Nhien
Viet do khong dap irng dieu kien ve GMP dbi vbi thire pham bao \e sue khoe. Cong tv dang xay dung nha may san xuat thire pham bao ve sue khoe theo lieu
- I huc pham bao ve sue khoe V1I-N BAO DUONG NGOC LI UN
PHONG NHUAN GAN SO 40 do Co so san xual Dong Nam Dupe Ngpe Lien
edng bo dope Cue An loan thpe pham cap Giay tiep nhan dang ky ban edng bo
IILU
ehuan GMP tai L6 A IV-3 va A IV-4. KCN Giao Long, xa An Phubc. huyen
Chau Thanh, tinh Ben Tre.
Tai thbi diem thanh tra ghi nhan tai Chi nhanh Cong t_\ Co phan I hie'n
Nhien Viet (dia chi: Ap Long Hoa. Xa Dao Ihanh. I hanh phb My I ht). lien
Giang) khong san xual thpe pham bao ve sue khoe: tai kho Chi nhanh C ong l\ khong eo san pham thpe pham bao ve sue khoe.
(5) . Quiing cao san pham:
Theo bao cao cua Cong ty Co phan I hien Nhien Viet. Cong ly eo
website: vietnat.vn. Cong ty hien tai dura thpe hien quang eao eae san pham
thpe pham bao ve sue khoe eua Cong ty tren website nay.
Tai thbi diem thanh tra. Doan thanh tra ghi nhan website: vietnat.vn
khong quang eao eae san pham thpe pham bao \e sue khoe eua Cong t\.
(6) . Lay man kiem nghiem: Doan thanh tra khong la\ man
5. Co so' san xuat Dong Nam Dupe Ngpe Lien, clja elu: 127/9 Le I hi I Icing Gam, PhircVng 6, thanh Pho My Tho, tinh Tien (bang
(1) lib so hanh ehinh, phap ly eua eo so:
Giay ehung nhan eo so du dieu kien an loan thpe pham so: 28/2018/ATTP-CNDK ngay 17/7/2018 do Chi cue An loan ve sinh thpe pham
tinh Tien Giang cap eho Co so san xuat Dong Nam Dirge Nggc Lien.
(2) . Cong bb san pham:
l ai thbi diCan thanh tra. Co so san xual Dong Nam Dupe Ngpe Lien bao
eao: Co so cbng bb 09 hb so eon hieu lire, cu the:
- Thpe pham bao ve sire khoe bb phe giam ho so 5 do Co so san xual Dong Nam Dupe Ngpe Lien cbng bb dirge Cue An loan thpe pham cap Gih\ tiep nhan dang ky ban cbng bo so 10089/2018/DKSP nga> 12'12/2018.
- Thpe pham bao ve sire khoe TILU PIIONCi NIIUAN GAN SO 40 do
Co so san xuat Dong Nam Dupe Nggc Lien cbng bb dupe Cue An loan thpe
pham cap Giay tiep nhan dang ky ban cbng bb so 9536/201H/DKSL ngav
28/11/2018.
- Thpe pham bao ve sue khoe Da da) do Co- so san xuat Dong Nam Dupe
Ngpe Lien cbng bb dupe Cue An loan thpe pham cap Gia\ tiep nhan dang ky
ban cbng bo sb 10088/2018/DKSP ngay 12/12/2018.
- Thpe pham bao ve sue khoe NGOC L1LN SOI T1 IAN I lO.AN do Co sb
san xuat Dong Nam Dupe Ngpe Lien cbng bb dupe Cue An loan thpe pham cap
Giay tiep nhan dang ky ban cbng bb sb 9535 2018 DK.SP ngay 28/1 1 201 8.
- Thirc pham bao ve sue khoe NGOC MEN SOI THAN HOAN. 16 SX: 010619, NSX 010619, HSD: 30 thang ke tir nga\ san \ual: Noi dung ghi nhan
phu hap vai nhan do Co so san xuat Dong Nam Dirge Ngge I ien cong bo dirge
Cue An loan thirc pham cap Giay tiep nhan dang ky ban eong bo so
9535/2018/DKSP ngay 28/11/2018.
- Thirc pham bao ve sire khoe Da day, 16 SX: 010818, NSX 050818. USD: 050821: Noi dung ghi nhan phu hgp vai nhan do Ca sa san \uat Dong
Nam Dirge Ngge Lien eong bo dirge Cue An loan ilurc pham cap Gia\ liep nhan dang ky ban eong bo so 10088/2018/DKSP nga\ 12/12/ 201 8.
- Thirc pham bao ve sue khoe TIED PHONG NHUAN GAN SO 40. 16 SX: 010119, NSX 030119, HSD: 030721: Noi dung ghi nhan phu hgp vai nhan
do Ca so' san xuat Dong Nam Dirge Ngge Lien eong bo dirge Cue An loan dure pham cap Giay tiep nhan dang ky ban eong bo so 9536/2018/DKSP nga\ 28/1 1/2018.
- Thirc pham bao ve sire khoe Giai earn giam nhire moi, 16 SX: 010818. NSX 090818. HSD: 090821: Noi dung ghi nhan phu hgp vai nhan do Ca so' san
xuat Dong Nam Dirge Ngge Lien eong bo dirge Cue An loan thirc pham cap
Giay tiep nhan dang ky ban eong bo so 10087/2018/DKSP nga\ 12/12/2018.
- Thirc pham bao ve sue khoe bo phe giam ho so 5. 16 SX: 010519. NSX
160519, HSD: 160522: Noi dung ghi nhan phu hgp vai nhan do Ca sa san xuat Dong Nam Dirge Ngge Lien eong bo dirge Cue An loan ilurc pham cap Gia\ liep nhan dang ky ban eong bo so 10089/2018/DKSP ngay 1 2/12/201 8
- Thue pham bao ve sue khoe T1EIJ PHONG NHUAN GAN SO 40. 16
SX: 010519, NSX 310519. HSD: 36 thang ke tir nga\ san xuat: Noi dung ghi nhan phii hgp vai nhan do do Ca sa san xuat Dong Nam Dirge Ngge I ien eong
bo dirge Cue An loan thirc pham cap Giay tiep nhan dang ky ban eong bo so
9536/2018/DKSP ngay 28/11/2018
(4). Dieu kien bao dam an toan thirc pham
Doan thanh tra ghi nhan theo bao eao eiia Ca sa san xuat Dong Nam Dirge
Ngge Lien: Truae ngay 01/07/2019. Ca sa san xuat Dong Nam Dirge Ngge Lien
san xuat tai ca so' theo Giay chung nhan ca sa du dieu kien an toan thue pham
so: 28/2018/ATTP-CNDK ngay 17 7 2018 do Chi cue An loan \e sinh thue
pham linh Tien Giang cap. Tir ngay 01/07/2019 den na>. Ca sa san xuat Dong
Nam Dirge Ngge Lien da ngirng san xuat thue pham bao ve sire khoe tai Ca sa
san xuat Dong Nam Dirge Ngge Lien do khong dap irng dieu kien \e GMP doi vai thire pham bao ve sire khoe.
Tai thai diem thanh tra ghi nhan tai Ca sa san xuat Dong Nam Dirge Ngge
Lien, dia chi: 127/9 Le Thj Hong Gam. Phirang 6. thanh Pho My Tho. linh I ien
14
Giang khong san xuat thuc pham bao ve sue khoc: tai kho Co- so- san xuai Dong
Nam Dirge Ngge Lien liru man 08 san xuat thuc pham bao ve sue khoe.
(5) . Quang cao san pham:
Theo bao eao ci’ia Co so' san xuat Dong Nam Dirge Ngge Lien, ('o' so
khong co website, Co so khong thuc hien quang eao cac san pham tlure pham
bao ve sire khoe.
(6) . Lay man kiem nghiem: Doan thanh tra khong lay man
III. KET LUAN
1. Cong ty TNI 111 Mot lhanh vien I lien Ilai Phat. dja chi: So 69CL duong
so 1, khu Pho My Tan, plurong 7, thanh pho Ben Tre, tinh Ben Tre
(1) . Cac noi dung eo so thire hien dung: Cong ty da co Giay ehirng nhan
dang k\ doanh nghiep; eae san pham Cong t\ kinh doanh tai thdi diem lhanh tra
eo ho so eong bo eon hien lire.
(2) . Cac hanh vi vi pham, ton tai:
Cong ty TNI III Mot thanh vien Hien Hai Phat vi pham qu\ dinh ve noi dung bat huge tren nhan hang hoa doi voi 02 Id san pham tlure pham bao ve sue
khoe sau:
i Thuc pham bao ve sue khoe HEMO VEIN
010618, NSX 16/6/18, USD: 15/06/21: Noi dung ghi nhan khong phu hgp vdi nhan do Cons tv TNI 111 Mol thanh vien Mien Ilai Phat cbng bo diroe Cue An loan tlure pham cap Giay tiep nhan dang ky ban edng bd so 2746/201 8/DkSP
ngay 21/5/2018. eu the: Nhan ghi them noi dung ve edng dung, thanh phan Cao
diep ca theo noi dung tren nhan la 250mg (noi dung hd so' edng bd la 200mg).
i Thuc pham bao ve sue khoe Calmax Pluss Nhat l am. Id SX: 180633. NSX 16/08/18, USD: 15/08/21: Noi dung ghi nhan khong phu hgp vd'i nhan do Cong tv TNHH Mot thanh vien Hien Hai Phat edng bd dirge Cue An loan thire
pham cap Giay tiep nhan dang ky ban edng bd so 4290/2018/DKSP ngav
12/7/2018. eu the: Nhan ghi them noi dung ve edng dung, ddi tirgng sir dung
2. Cong ty co phan Sa Sam Viet, dja chi: So 430C1 Nguyen Hue, Phudng Phu Klurong, thanh pho Ben Tre, tinh Ben I re
(1) . Cac noi dung eo so thire hien dung:
- Cong ty da co Giay cluing nhan dang ky doanh nghiep.
- Kiem tra hd so 08 san pham thire pham bao ve sire khoe cua Cong tv ghi nhan hd so edng bd cac san pham eon hien lire: ndi dung ghi nhan phu hop vdi nhan trong hd so' edng bd dirge Cue An loan thire pham xac nhan.
(2) . Cac hanh vi vi pham. ton tai: Khong ed
II NHAT rAM. Id SX:
15
san pham thirc pham bao ve sire khoe vi pham 1)11) dinh ve nbi dung bat bude
tren nhan hang boa. bao dam nhan san pham lim hanh dung \ di cong bd.
2. Doi vdi cac co sd tren dia ban tinh Tien (iiang. C ue An loan tlure pham
giao Chi cue An loan ve sinh thire pham tinh T ien (iiang giam sat boat dong san
xuat, kinh doanh thue pham bao ve sire khoe doi vdi cac co' sd tren dia ban. Giam sat boat dong cua Co' sd san xuat Dong Nam Dupe Ngpc Lien va C dug l\ Cd phan Thien Nhien Viet, 02 co' sd nay dang lam ngirng san xuat thue
pham bao ve sue khoe tu ngay 01/7/2019 den thdi diem thanh Ira do khdng dat yen can thue hanh san xuat tot (GMP). bao dam co so thue hien dung quy dinh
ve dieu kien an loan thue pham doi vdi eo sd san xuat thire pham bao ve sue khoe quy dinh tai Nghj dinh sd 15/2018/ND-CP \ a T hong lir so 18 2019 T T - BYT ngay 17/7/2019 cua Bo tnrdng Bp Y te.'.qj^^
T IU/ONC.VV^Noi nluin:- Bo tnrong (de bao cao):- Thir H uong Truong Quoc Cuong (de bao cao);- riianh Ira Bo Y te (de biet);- PC T. Do Huu Tuan (de biet);- Thanh tra So' Y te Ben Tre, Tien Giang (de biet);- Chi Cue ATVSTP Ben Tre. Tien Giang (de thue hien):- Cong ly TNHH Mot thanh vien Hien Hai Phat. Cong t\ co phan Sa Sam Viet. Cong ly Co phan Dupe pham TIPHARCO, Cong ty Co phan Thien Nhien Viet. Co so san xuat Dong Nam Dirge Ngpc Lien (de thue hien);- Website Cue AT I P (de cong khai):- Liru: VT. PCTTR.
psiCcue
Icf ANTOA \THl/C PH/
C-:-Ao
Nguyen Thanh Phong
18