Food and Drag Administration Establishment lnspection Report Inspection report 1.pdf · Food and...
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Food and Drag Administration Establishment lnspection Report . . . ' ,. . .. 3. *; ' 1 .. ~. b, .. ,\. .. .. .l . + , - - . . . . .. -. Date Assigned: 12 I I 2008 Inspection Start Date: 03 12 200'1 Inspection End Date: 03 12 200'1 Firm Name &Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US Firm Mailing Address: 201 Airside Drive, Danville, VA 24540 United States FEI: 1122474 JDmA: 3F County:DANVILLE Est Size: Phone: (434)822-4000 District: BLT-DO Profiled: No Conveyance Type: % 1nterstate:m Inspectional Responsibility: State Contract and Joint FDA/USDA Endorsement "This was a m u t i e contract inspection of a manufacturer / processor. (Products: Pasata Sauces, Pasta, Cookie Dough) The previous 7/22/2008 inspection was classified NAI and findings included: No objectionable conditions were observed during the inspection. Corrections since last insp: N/A. The firm's operation hours are 3:OOam - 1:00am - Seven daydweek depending on sales. Office hours are 8:OOam - 5:OOpm - Mon - Fri. ~ p p r o x i m a t e l ~ ~ Establishment size =I. of products under FDA's coverage are distributed interstate. Wholesale output i s l l m = There have been no establishment changes. The fm is registered. Food security and BT Registration Act information was providcd to the firm. CURRENT FINDWGS: No unsanitary conditions noted. See state inspection report for list of observed GMP deficiencies. General areas of deficiencim observed include: FALSE. Coporate policy on refusal to sign inspection report. No samples were collected. A report of this inspection was provide to Ms. Jan Hams - Plant Manager - Floyd Caldwell - Quality Assurance Manager. Corrections during inspection andfor promised: N/A NOTE: No unsanitary conditions noted. Firm inspected by: Bud Anderson Inspection Classified: NAI lollow-up Lnrpcction. Routine Coverage 3 2010 I.DA Distnbut~on One - to U1.T file." SCM Remarks for State Inspection: Endor~ment Location: Inspector Name Date & Time of Signature Supervisor Name Date & Time of Signahlre ET Nathaniel R Esaw 03/24/2009 05:28 PM ET Date: 06/22/2009 Page: 1 of 6
Transcript of Food and Drag Administration Establishment lnspection Report Inspection report 1.pdf · Food and...
Food and Drag Administration Establishment lnspection Report . .
. ' ,.. .. 3. * ; ' 1 . . ~. b, . . , \ .
.... .l. + ,- -. . . . .. - . Date Assigned: 12 I I 2008 Inspection Start Date: 03 12 200'1 Inspection End Date: 03 12 200'1
Firm Name &Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US
Firm Mailing Address: 201 Airside Drive, Danville, VA 24540 United States
FEI: 1122474 JDmA: 3F County:DANVILLE Est Size:
Phone: (434)822-4000 District: BLT-DO Profiled: No
Conveyance Type: % 1nterstate:m Inspectional Responsibility: State Contract and Joint FDA/USDA
Endorsement "This was a m u t i e contract inspection of a manufacturer / processor. (Products: Pasata Sauces, Pasta, Cookie Dough)
The previous 7/22/2008 inspection was classified NAI and findings included: No objectionable conditions were observed during the inspection. Corrections since last insp: N/A.
The firm's operation hours are 3:OOam - 1:00am - Seven daydweek depending on sales. Office hours are 8:OOam - 5:OOpm - Mon -Fri. ~ p p r o x i m a t e l ~ ~ Establishment size =I. of products under FDA's coverage are distributed interstate. Wholesale output i s l l m =
There have been no establishment changes.
The fm is registered. Food security and BT Registration Act information was providcd to the firm.
CURRENT FINDWGS: No unsanitary conditions noted. See state inspection report for list of observed GMP deficiencies. General areas of deficiencim observed include: FALSE. Coporate policy on refusal to sign inspection report. No samples were collected.
A report of this inspection was provide to Ms. Jan Hams - Plant Manager - Floyd Caldwell - Quality Assurance Manager. Corrections during inspection andfor promised: N/A
NOTE: No unsanitary conditions noted.
Firm inspected by: Bud Anderson Inspection Classified: NAI lollow-up Lnrpcction. Routine Coverage 3 2010 I.DA Distnbut~on One- to U1.T file."
SCM Remarks for State Inspection: E n d o r ~ m e n tLocation:
Inspector Name Date & Time of Signature Supervisor Name Date & Time of Signahlre ET Nathaniel R Esaw 03/24/2009 05:28 PM ET
Date: 06/22/2009 Page: 1 of 6
Firm Name & Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US
Related Firm FEI: Name & Address of Related Firm:
Registration Type Regish.ation Dates FFR Food 10/30/2003
Establishment Type Industry Code M Manufacturer 03 Bakery ProdlDoughlMixlIcing
M Manufacturer 04 MacaroniMoodle Prod
M Manufacturer 25 VegetablesNegetable Products
M Manufacturer 37 Mult Food DinnedGrav/Sauce/Special
WZ Warehouse-Ambient, Refrigerated, and Frozen Storage 47 Multiple Food Warehouses
District Use Code: 1 TO BE EDITED 2 TO BE EDITED
Date: 06/22/2009
I
Food and Drug Administration Establishment Inspection Report
FEI: 1122474 Inspection Start Date: 03/12/2009 Inspection End Date: 03/12/2009
Firm Name &Address: Nestle USA, lnc. ,201 Airside Dr Danville, VA 24540-5616 US
Inspectioo Basis: Surveillance
Inspected Processes & District Decisions Products1 MQSA Reschedule Re-Inspection Inspection
PAC Establishment Type Process lnsp Date Priority Conclnsions 03S001 Manufacturer 0 3 M G C No Action Indicated (NAI
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name
03/24/2009 No Action Indicated (NAI) Agency, State BLT-DO
Remarks:
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name Y 03/24/2009 No Action Indicated (NAI) Esaw, Nathaniel R BLT-DO
Remarks:
Productsl MQSA Reschedule Relnspection Inspection PAC Establishment Type Process lnsp Date Priority Conclusions
03S00 1 Manufacturer 37 J H N No Action Indicated (NAI
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name
03/24/2009 No Action Indicated (NAI) Agency, State BLT-DO
Remarks:
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name Y 03/24/2009 No Action Indicated (NAI) Esaw. NathanieI R BLT-DO
Remarks:
Products1 MQSA Reschedule Re-Inspection Inspection PAC Establishment Type Process Insp Date Priority Conclusions
03S001 Manufacturer W A G T No Action Indicated (NAI
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name
03/24/2009 No Action Indicated (NAI) Agency, State BLT-DO
Remarks:
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name Y 03/24/2009 No Action Indicated (NAI) Esaw, Nathaniel R BLT-DO
R e m a r k
Date: 06/22/2009 Page:3 of 6
Food and Drug Administration Establishment Inspection Report
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FEI: 1122474 Inspection Start Date: 0311212009 Inspection End Date: 03/12/2009 I1 Firm Name & Address: Nestle USA, Inc., 201 Airside Dr Danville, VA 24540-5616 US i
Products Covered Additional Product
Product Code Est Type Description Description 03 M G C 04 Manufacturer Toll House Cookie, Biscuit,Wafer Dough; Plastic, Synth;
Raw, Fresh, Refrigerated 04 A G T 05 Manufacturer Spaghetti; Plastic, Synth; Packaged Food (?lot Commercially
Sterile) 37 1 H N 99 Manufacturer Sauces, n.e.c.; Nonflex Plastic; Heat Treated
Assignees Accomplishment Hours Employee Name Position Class Hours Credited To PAC Establishment Type Process Hours Agency, State STA BLT-DO 03S001 Manufacturer 0 3 M G C 4 Agency, State STA BLT-DO 03S001 Manufacturer 3 7 1 H N 4 Agency, State STA BLT-DO 03S001 Manufacturer O4A G T 4
rota1 Hours: 12
Date: 06/22/2009
Food and Drug Administration Establishmot Inspection Report
FEI: 1122474 Inspection Start Date: 0311212009 Inspection End Date: 0311 212009
Firm Name & Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US .~---. . .
Inspection Result
EIR Location Trips Num
Inspection Surnrnaly "LEGAL STATUS OF FIRM: incorporated in Delaware.
CORPORATE INFORMATION: Nestle Inc. - 800 North Brand Blvd. - Glendale, CA 81203 -Mr. Bradley Alford COPICEO
PRIOR REGULATORY ACTlONS I WARNINGS: NIA
RECALLS I PRODUCT REMEDIATION: BIA
MOST RESPONSIBLE PERSON IN CHARGE: Ms. Ian Harris -Plant Manager - Floyd Caldwell- Quality Assurance Manager
ESTABLISHMENT CHANGES: None
NUMBER OF EMPLOYEES AND OVERVlEW OF OPERATIONAL PROCEDURES: Nestle employs approximatelym employees. The company operates& . The plant manufactures pasta and pasta sauces under the Buitoni brand name and eookie dough under the Tollhouse brand name. The company h a s m pasta processing production l i n e s , m pasta sauce processing production l i e s , a n d a cookie dough processing reduction lines. Nestle processes meat filled pasta on-site and is under USDANDACS inspection. They receive most goods via
transport and have three silos outside the fm for grain storage. Nestle also has another off site warehouse for stora e of kgmaterials. Nestle does process peanut cookies with the peanut pnducts being purchased and supplied b y d I A -PRODUCTS - Peanut Butter
(smooth) - Peanut Butter paste. "
TB Suggested Actions Action Remarks
Referrals Org Name Mail Code Remarks
Refusals
lnspection Refusals: No refusal
Samples Collected Recall Numbers Related Complaints Sample Number Recall Number Consumer Complaint Number
FDA 483 Responses
483 lssued?: 483 Location:
Date: 0612212009 Page: 5 of 6
i Food and Drug Administration Establishment Inspection Report
FEI: 1122474 inspection Start Date: 03/12/2009 Inspection End Date:0311212009
Firm Name & Address: Nestle USA, Inc., 201 Airside Dr Danville, VA 24540-5616 US
Response Type Response Response Response Summary Mode Date
Date: 0612212009 Page: 6 of 6
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/ Date Assigned: 11/27/2007 Inspection Start Date: 11/01/2007 Inspection End Date: 11/02/2007
Firm Name & Address: Nestle USA, lnc. ,201 Airside Dr Danville, VA 24540-5616 US
Firm Mailing Address: 201 Airside Drive, Danville, VA 24540 United States
FEI: 1122474 JDTTA: 3F Conoty:DANVILLE Est Size: Phone: (434)8224000 ~ i s t f i e t : BLT-DO Profiled: No
Conveyance Type: % 1nterstate:m Inspedional Resp0nsihility:State Contract and Joint FDAiUSDA
Endorsement "This was a routine contract inspection of a manufacturer and warehouse. (Manufactured - Refrigerated pasta, pasla sauces and cookie dough; Warehoused - Refrigerated pasta, pasta sauces and cookie dough)
The previous 2/21/2007 inspection was classified VAI and findings included: ""Toll House"" preparation: 1-Miscellaneous tooldequipment stored in hand washing sink. 2-The drain from the hand washin sink was leaking onto the floor. 3-The control pedal for the cold watenvas missing from the sink in the ""powdered sugar"" room. ' * #14"": 4-Water was dripping fivm the valve on the cold water line. 5-A hole was found in the steam line above was exposlng I rons insulation. ""Toll House Receiving"": 6-The perimeter of the floors in the ""shipping warehouse"" and the hallway were peppered with wood splinters, dust. cardboard lint, and unidentifiable particles. Corrections since last insp: Corrected items marked on last inspection.
The firm's operation hours are& depennin on roduction needs. Approximately products under FDA's coverage are distributed interstate. Wholesale output i s b e Establishment size 4See SUMMARY for details of eslablishment changes.
The firm is registered. F w d security and BT Regishation Act information was provided to the fum.
CURRENT FINDINGS: See slate inspection report for list of obscrved GMP deficiencies. General areas of deficiencies observed include: Equipment, Employee Practices. Refusal to allow photography, review of production records, processing controls, complaint files Samples Collected: #04500026 - Marinara Sauce - One15 oz plastic container.
A report of this inspection was provide to Mr. Lany Hundycz - Plant Hygienist - QA Tech.Corrections during inspection andlor promised: Corrected concerns with metal detector on pasta hand towles at handsink on cookie dough processing line (shut donw at time of inspection).
Finn inspected by: Bud Anderson Inspection Classified: 37 Follow-up Inspection: Routine Coverage 1112008 FDA Distribution: Orig to BLT file."
SCM Remarks for State Inspection: REPORT: \\Orscrhltdo01\hlt teams\State Reports\VDACS\2007 - 2008Westle USA Inc 07-11- 0 2 . ~ 1 ~ Endorsement Loeation:
Inspector Name Date & Time of Signature Supervisor Name Date & Time of Signature ET Nathaniel R Esaw 06/13/2008 02:31 PM ET
Date: 06/22/2009 Page: 1 of 6
I Food and Drug Administration Establishment Inspection Report
FE1: 1122474 inspection Start Date: 11/01/2007 Inspection End Date: 11/02/2007 Firm Name &Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US
Related Firm FEl: Name & Address of Related Firm:
Registration Type Registration Da t a FFR Food 10/30/2003
Establishment Type Industry Code
M Manufacturer 03 Bakery ProdlDough~MixIIcing
M Manufacturer 04 Macaronimoodle Prod
M Manufach~rer 25 VegetablesNegetable Products
M Manufacturer 37 Mult Food Dinner/GravlSauee/Special
WZ Warehouse-Ambient, Refrigerated, and Frozen Storage 47 Multiple Food Warehouses
District Use Code: I TO BE EDITED 2 TO BE EDlTED
Date: 06/22/2009 Page: 2 of 6
FE1: 1122474 Inspection Start Date: 11/01/2007 Inspection End Date: 1 l/OZ/2007 I Firm Name & Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US
i Inspection Basis: Survei~kmce
Inspected Processes & District Decisions Products1 MQSA Reschedule Re-Inspection Inspection
PAC Establishment Type Process Insp Date Priority Conclusions 03S001 Manufacturer 0 3 M G C No Action Indicated (NAI
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name
04/23/2008 No Action Indicated (NAI) Agency, State BLT-DO
Remarks:
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name Y 06/13/2008 No Action Indicated (NAI) Esaw, Nathaniel R BLT-DO
Remarks:
Products1 MQSA Reschedule Re-Inspection Inspection PAC Establishment Type Process Insp Date Priority Conclusions
03S001 Manufacturer 0 4 A G T No Action Indicated (NAI
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name
04/23/2008 No Aetion Indicated (NAO Agency, State BLT-DO
Remarks:
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name Y 06/13/2008 No Action Indicated (NAI) Esaw, Nathaniel R BLT-DO
Remarks:
Products/ MQSA Reschedule Re-Inspection Inspection PAC Establishment Type Process Insp Date Priority Conclusions
03S001 Manufacturer 3 7 J H N No Action Indicated (NAI
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name
04/23/2008 No Action Indicated (NAI) Agency, State BLT-DO
Remarks:
Final District District Decision Decision? Decision Date District Decision Type Made By Org Name Y 06/13/2008 No Action Indicated (NAI) Esaw, NathanieI R BLT-DO
Remarks:
Date: 06/22/2009 P a g e 3 of 6
Food and Drug Administration Establishment Inspection Report
1 FEI: 1122474 Iuspectiou Start Date: 11/01/2007 Inspection End Date: 11/02/2007
I !Firm Name &Address: Nestle USA, lnc. ,201 Airside Dr Danville, VA 24540-5616 US . .- ~~. -. .. . ......J
Products Covered AdditionaI Product
Product Code Est Type Description Description 03 M G C 04 Manufacturer Toll House Cookie, Biscuit,Wafer Dough; Plastic, Synth;
Raw, Fresh, Refrigerated 04 A G T 05 Manufacturer Spaghetti; Plastic, Synth; Packaged Food (Not Commercially
Sterile) 37 I H N 99 Manufacturer Sauces, n.e.c.; Nonflex Plastic; Heat Treated
Assignees Accomplishment Hours Employee Name Position Class Hours Credited To PAC Establishment Type Process Hours Agency, State STA BLT-DO 03S001 Manufacturer 0 3 M G C 4
Agency, State STA BLT-DO 03S001 Manufacturer 0 4 A G T 4
Agency, State STA BLT-DO 03S001 Manufacturer 3 7 1 H N 4
rota1 Hours: 12
Date: 06/22/2009
Food and Drug Administration Establishment Inspection Report
FEI: 1122474 Inspection Start Date: 11/01/2007 Inspection End Date: 11/02/2007
Firm Name & Address: Nestle USA, Inc., 201 Airside Dr Danville, VA 24540-5616 US
Inspection Result
E m Location Trips Num
lnspection Summary "LEGAL STATUS OF FIRM: Incorporated in Deleware.
CORPORATE INFORMATION: Nestle Holding Inc. - 800 Nonh Brand Blvd. - Glendale CA 91203 Mr. Bradley Alford COPICE0
PRIOR REGULATORY ACTIONS / WARNINGS: N/A
RECALLS 1PRODUCT REMEDIATION: Company has both an intcmal and exteranl recall process. All product is coded for recall. All in-house product is held until cocnerns can be corrected.
MOST RESPONSIBLE PERSON IN CHARGE: Mr. Jason M. Mabcn
ESTABLISHMENT CHANGES: size-
haskasta , tpas ta sauce anQ q o k i e F g h pro- lines. Nestle processes some meat filled pasta on-site and is under USDAlVA lnspechon (MI Erne Sples and Ms Heather Stumbo). NestIealso has an in-house allergen program. They receive most goods via t~ansport and h a v m silos outside for flour storage. They also have another off site warehouse for storing packaging. "
IB Suggested Actions Action Remarks
Referrals Org Name Mail Code Remarks
Refusals
Inspection Refusals: No refusal
Samples Collected Recall Numbers Related Complaints Sample Number Recall Number Consumer Complaint Number
FDA 483 Responses
483 Issued?: 483 Location:
Date: 06/22/2009
I Food and Drug Administration Establishment Inspection Report
II FEI: 1122474 Inspection Start Date: 1110112007 Inspection End Date: 11/02/2007 I !1 Firm Name & Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US I
Response Type Response Response Response Summary Mode Date
Date: 06/22/2009
1
Firm Name & Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US
Firm Mailing Address: 201 Airside Drive, Danville, VA 24540 United States
FEI: 1122474 JDm.4: 3F County:DANVILLE st sue:
Phone: (434)822-4000 District: BLT-DO Profiled: No
/ Conveyance Type: % 1nterstate:m InspectionaI Responsibility: State Contract and Joint FDARlSDA
Endorsement EIR link - H:\State Reports\VDACS\06-07WestleUSA Inc - VAl.xls
This was a routine conhact inspection.
CURRENT FINDINGS: I-Miscellaneous toolslequipment were being stored in the hand washing sink in the "Toll House" preparation area 2-The drain from the hand washing sink in the "Toll House" oreparation area was leaking onto the floor. 3-The control pedal for the cold water flow at the hand washighink was missing from &e hand washing sink in the "powdered sugar" room. 4-Water was dripping from the valve on the cold water line above the ' 5-A hole was found in the steam line above the V. l 4 " 6-The perimeter of the floors in the "shipping ware ouse and the "Toll House Receiving" hallway were peppered with wood splinters, dust, cardboard lint, and unidentifiable particles
No refusals No samples were collected.
A report of this inspection was provide to Mr. Floyd Caldwell, Quality Assurance Managa. Corrections during inspection andlor promised: Toolsiequipment were removed from the hand sink and management stated that they would correct the other cited issues.
NOTE: Due to certificates of free sale the plant shall he inspected at no more than 6 month intervals. Previous inspection was conducted by FDA in 0912006. USDA inspector on site in facility also.
Firm inspected by: C.A.ThackstoniB.Anderson Inspection Classified: VAI Follow-up Inspection: Routine Coverage 812007 FDA Dishihution: Orig to BLT file. Endorsement Loeation: FACTS
lnspector Name Date & Time of Signature Supemsor Name Date & Time of Signature Cntrctmntr Esaw 06/29/2007 04:34 PM ET Nathaniel R Esaw 06/29/2007 05: 13 PM ET
Date: 0612212009 Page: 1 of 5
/ Firm Name & Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US Lp-~ .-...~ A
Related Firm FEI: Name & Address of Related Firm:
Registration Type Registration Dates FFR Food 1013012003
Establishment Type Industry Code
M Manufacturer 03 Bakery Prod/DoughiMix/Icing
M Manufachxer 04 MacaroniMoodle Prod
M Manufachxer 25 VegetableslVegetable Products
M Manufachxer 37 Mult Food DinnerlGravlSaucelSpecial
WZ Warehouse-Ambient, Refrigerated, and Frozen Storage 47 Multiple Food Warehouses
District Use Code: 1 TO BE EDITED 2 TO BE EDITED
Date: 0612212009 Page: 2 of 5
Firm Name & Address: Nestle USA, Inc., 201 Airside Dr Danville, VA 24540-5616 US
Inspeetion Basis: Surveillance
Inspected Processes & District Decisions
PAC 03S001
Establishment Type Manufactnrcr
Products/ Process 0 3 M G C
MQSA Reschedule Insp Date 08/2007
Re-Inspection Priority Surveillance
Inspection Conclusions
Correction Indicated (CI)
Final District Decision? Decision Date Y 06/29/2007
District Decision Type Voluntary Action Indicated (VAI)
District Decision Made By Esaw, Nathaniel R
Org Name VA-VDACS
R e m a r k
PAC 03S00 1
Establishment Type Warehouse-Ambient, Reftigeratcd, and Frozen Storage
Products/ Process 47
MQSA Reschedule Insp Date 0812007
Re-Inspection Priority Surveillance
Inspection Conclusions
Correction Lndicated (CI)
Final District Decision? Decision Datc Y 06/29/2007
District Decision Type Voluntary Action Indicated (VAl)
District Decision Made By Esaw, Nathaniel R
Org Name VA-WACS
Date: 06/22/2009 Pagc: 3 of 5
FEI: 1122474 Inspection Start Date: 0212012007 Inspection End Date: 0212112007
Firm Name & Address: Nestle USA, Inc. ,201 Airside Dr Danville, VA 24540-5616 US . ~- ~
Products Covered Additional Product
Product Code Est Type Description Description 03 M G C 04 Manufacturer Toll House Cookie, Biscuit,Wafer Dough; Plastic, Synth;
Raw, Fresh, Refigerated
Assignees Accomplishment Hours Employee Name Position Class Hours Credited To PAC Establishment Type Process Hours Esaw, Cntrctmntr STA BLT-DO 03S001 Manufacturer 0 3 M G C 6
Esaw, Cntrctmntr STA BLT-DO 03S001 Warehouse-Ambient, Refr 47 6
rota1 Hours: 12
Date: 0612212009
FEI: 1122474 Inspeciion Start Date: 0212012007 Inspection End Date:0212112007
Firm Name & Address: Nestle USA, Inc. ,201 Airside Dr Danvine, VA 24540-5616 US
Inspection Result
EIR Location Trips Num FACTS
Inspection Summary See enodrsement.
IB Suggested Actions Action Remarks
Referrals Org Name Mail Code Remarks
Refusals
Inspection Refusals:
Samples Collected Recall Numbers Related Complaints Sample Number Recall Number Consumer Complaint Number
FDA 483 Responses
483 Issued?: 483 Location:
Response Response Response Type Mode Date Response Summary
Date: 0612212009 Page: 5 of 5
