EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Darren S Brown, I nvestigat or ·~,. 1 0/4 /201 6 OF THIS PAGE Jeffery A Johnson, Generic Dru g User Fee X Darren S Brown

Amendments (GDUFA) ........... ~-"" Sq'ltdb(: cw.....,._-s

FORM FDA 483 (09108) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSER VATIONS PAGE I OF 5PAGES

DEPARTM ENT OF HEALTH AND HUMAi'l SERVIC ES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER

2221 5 26th Ave SE Su ite 2 1 0 Bothell, WA 98021 (425)302 - 03 4 0 Fax : (425)302 - 0 4 0 4

OATE(S) OF INSPECTION

9/26/201 6 - 1 0/4 /201 6* FEI NUMBER

3003429652

NAME AND TI'TLE OF INDIVIDUAL TO WHOM REPORT ISSUED

Ronald P . Du lwick Owner ' F IRM NAME

Strohecker ' s Pharmacy

STREET ADDRESS

1286 SE Holgate Blvd C1 CITY. STATE. ZIP CODE. COUNTRY

Port land, OR 97282

TYPE ESTABLISHMENT INSPECTED

Producer of Steri le Produ c t s

TI1is docwuent lists observations made by the FDA representative{ s) during the inspection ofyour facility. TI1ey are inspectional observations, and do not represent a final Agency determination regarding your compliance. Ifyou have an objection regarding an observation, or have implemented, or p lan to implement, con·ective action in response to an observation, you may discuss the objection or action with the FDA representative{s) dwmg the inspection or submit this infollllation to FDA at the address above. Ifyou have any questions, please contact FDA at the phone muuber and address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1 Aseptic processing areas are defi cient regarding the system for monitoring environmental conditions.

Specifically,

•

•

•

The fum provided a report fro m the contract vendor on th e smoke study qualification of the sterile production suites; however no video was taken of the smoke study and no description of the conditions dming the sm oke study was provided, so no confnmation of the sm oke study could be reviewed. Additionally, no dynamic conditions to mimic sterile compounding were

perf01m ed dming the initial sterile compounding suite qualification .

Envirorunental monitoring is only perf01m ed l (6) ('4) SOP No.9 "EnvironmentalI· Monitoring/Testing" Revised/Reviewed: June 8th, 2016 states the following : Section 2 "Air

sampling shall be done [-( 6r(4)l", Section 3 "Sm face Testing shall be done eveiy f{6r(4)l ", and Section 6 "Verify the compounding areas meet USP <797> ISO 8, ISO 7, an d ISO 5 air

quality requirem ents". "Testing is to be completed eve1y l (6) ('4) I"· Additionally, no pruiiculate (non-viable) or microbial (viable) monitoring is perfon ned dming sterile production .

Personnel monitoring is only perf01med I <6r(4Y 1. No personnel microbial monitoring is perfon ned dming or after sterile production. SOP No. 12 "Glove fmge1iip sampling procedm e and documentation" Revised/Reviewed: June 27th, 2016 states ' '~0) (4~

(b) (4) j" is deficient in that it does not requir e operators to roll their r

DEPARTM ENT OF HEALTH AND HUMAi'l SERVIC ES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER OATE(S) OF INSPECTION

2221 5 26th Ave SE Suite 2 1 0 9/26/201 6 - 1 0/4 /201 6 * FEI NUMBERBo thell , WA 98021 3003429652(4 25)302- 03 4 0 Fax : (4 25)302- 0 4 0 4

NAME A ND TI'TLE OF INDIVIDUAL TO WHOM REPORT ISSUED

Rona ld P . Du l wic k , Own er F IRM NAME STREET ADDRESS

Strohec ker' s Pharmac y 1286 SE Holgate Bl v d C1 CITY. STATE. ZIP CODE. COUNTRY

Po rt l a nd , OR 9 7 282

TYPE ESTABLISHMENT INSPECTED

Produ c er o f Steri l e Produ c t s

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Darren S Bro wn , I nves tigato r ·~,. 1 0/4 /201 6 OF THIS PAGE Jeffery A J o h nson , Ge n eric Drug User Fee X Darren S Brown

Amen dme n t s (GDUFA) ........... ~-"" Sq'ltdb(: cw.....,._-s

FORM FDA 483 (09108) PREVIOUS EDmON OBSOLETE INSPECTIONAL OBSER VATIONS PAGE 2 OF 5PAGES

fingettips fro m side to side.

SOP No. 13 "Garbing, Gowning and Gloving Process, Aseptic Teclmique Processes and Cleaning Processes Validation and Documentation" Revised/Reviewed: June 7th, 2016 is deficient in that it does not require any sampling of the gown such as forehead, face , shoulder, or chest areas.

OBSERVATION 2 Procedm es designed to prevent microbiological contamination of dm g products pmporting to be sterile are not established.

Specifically,

•

•

SOP No. 10 "Garbing Procedm e Teclmique" Revised/Reviewed: June 2nd, 2016 is deficient in th at it does not state that face and neck areas should be completely covered. Fmthetmore, it does not address the exposm e of street clothing in th e IS07 room with 1 ISO 5 hood. On 09/26/1 6, we observed an employee ~(o)(6),(5J(7)(C~) working in the ISO 7 room with 1 ISO 5 hood exposed face, neck area, an d street clothing while filling sterile Leuprolide Microdose 40

MCG/0.2 ML Injectable, Lot# LM-0926S16, [ (6) (~) batch.

There is no written procedm e and no qualification ofth e [( 6) (~)] sterilization for the (6) (~lf %%(4) model r (6r(4Yl (S ((6r(4)]2) or the I (b) (4) model l(b) (4)J

6r(4r I) use to sterilize dmg products. NoI (b) (4) has been perf01med and no I -(6} 4 ) 1qualification has been perf01med. The following batches were produced and sterilized by -(or(4 1:

Product Date Made Lot Sterilization

Estradiol Valerate in Cottonseed 7/2112016 E-072 1S16 Method

(or ~) r

DE P ARTM ENT OF HEALTH AND HUMAi'l SE RVIC E S FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS AND PHONE NUMBER OATE(S) OF INSPECTION

2221 5 26th Ave SE Su ite 2 1 0 9/26/201 6 - 1 0/4 /201 6 * FEI NUMBER Bo thell , WA 98021 3003429652(4 25) 302 - 0 34 0 Fax : (4 25) 302 - 0 4 0 4

NAME A ND TI'TLE OF INDIVIDUAL TO WHOM REPORT ISSUED

Rona l d P . Du l wic k , Own er F IRM NAME STREET ADDRESS

Strohec ker' s Pharmac y 1286 SE Holgate Bl vd C1 C ITY. STAT E. Z IP CODE. COUNTRY

Po rt l a n d, OR 9 7 282

TYPE ESTABLISHMENT INSPECTED

Pro d u c er o f Steri l e Pro d u c t s

EMPLOYEE(S) SIGNATURE DAT E ISSUED

SEE REVERSE Darren S Brown , I nves tigato r ·~,. 1 0/4 /201 6 OF THIS PAGE Jeffery A J o h nson , Ge n eric Dr u g User Fee X Darren S Brown

Amen dmen t s (GDUFA) ........... ~-""Sq'ltdb(: cw.....,._-s

FORM FDA 483 (09108) PREVIOUS EDmON OBSOLETE INSPECTIONAL OBSERVATIONS PAGE 3 OF 5PAGES

Oil (5ML) 20MG/ML Injectable

-(oy­(LJJ 1Estradiol Valerate in Cottonseed

Oil (5ML) 20MG/ML Injectable 7/29/2016 E-0729S16

Estradiol Valerate in Cottonseed

Oil (5ML) 20MG/ML Injectable 8/26/2016 E0826S16 (b) (4) I

(c) (~) JProgesterone (Ethyl Oleate) 50MG/ML Injectable

7/28/2016 PE0-0728S 16

Progesterone (Ethyl Oleate) 50MG/ML Injectable

8/9/2016 0809S16 (b) (4) I

(b) (4) r

(c) (~) f

Progesterone (Ethyl Oleate) 50MG/ML Injectable

8/31/2016 PE0-0831 S 16

Testosterone Cypionate (Sesame Oil) 200MG/ML

Injectable

8/10/2016 T0810S16

Media fills do not simulate n01m al sterile production . The m edia fill for high risk production includes a media fill o:l (o) (~) j which does not represent all vial

1sizes such as 10 ml in a (b) (4) vial an d 2 ml in a (b) (4) vial.

OBSERVATION 3 Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.

Specifically,

• SOP No. 5 "Cleaning an d Disinfection" Revised/Reviewed: June 7th, 2016 is deficient in that it

does not state within the procedm e the type of cloth to be used when applying the smface

disinfectant. On 9/27/2016 we observedl(I:5)(6),(5)(7)(C~ cleaning the ISO 5 hood with non-sterile,

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE

Darren S Bro wn , I nJeffery A J o h nson , Amen dme n t s (GDUFA)

ve s tigato r Ge n eric Drug User Fee X Darren S Brown ...........

DATE ISSUED

1 0/4 /201 6

FORM FDA 483 (09108) PREVIOUS EDmON OBSOLETE INSPECTIONAL OBSERVATIONS PAGE40F 5 PAGES

DEPARTM ENT OF HEALTH AND HUMAi'l SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER

2221 5 26th Ave SE Suite 2 1 0 Bo thell , WA 98021 (4 25)302- 03 4 0 Fax : (4 25)302- 0 4 0 4

NAME A ND TI'TLE OF INDIVIDUAL TO WHOM REPORT ISSUED

Rona ld P. Du l wic k , Own er F IRM NAME

Strohec ker' s Pharmac y CITY. STATE. ZIP CODE. COUNTRY

Po rt l a nd , OR 9 7 282

STREET ADDRESS

OATE(S) OF INSPECTION

9/26/201 6 - 1 0/4 /201 6 * FEI NUMBER

3003429652

1286 SE Holgate Bl v d C1 TYPE ESTABLISHMENT INSPECTED

Produ c er o f Steri l e Produ c t s

•

•

. However no evaluation has been m ade on the pmiiculate load the duster m op heads may introduce into the ISO 7 and ISO 5 environments . ar e located in the

OBSERVATION 4 Master production and control records lack complete manufacturing and control instru ctions .

Specifically, the fi1m does not have a light box for the examination of compmmded vials for the presence ofpmiiculate matter. As described by (o)(6),{6}{7J{C] , the examiner (o) (4)

and D 4 looking for pmiiculate m atter. The majority of the finn ' s sterile --.~-·.-"""!production is within amber vials which may be difficult to observe for pmiiculate matter. The finn only uses a b 4 for the presence ofpmiiculate matter; there is no dai·k backgrmmd to inspect for pmiiculate matter that would not be visible with a white or light background. (Additionally, there is no eye examination or personnel qualification requirement for the examination of vials for pmiiculate matter.

*DATES OF INSPECTION 9/26/2016(Mon),9/27/2016(Tue ),9/28/2016(Wed),9/30/2016(Fri), 1 0/03/2016(Mon), 1 0/04/2016(Tue)

DEPARTMENT OF HEALTH AND HUMAi'l SERVICES FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS AND PHONE NUMBER OATE(S) OF INSPECTION

2221 5 26t h Ave SE Suit e 21 0 9/26/201 6 - 1 0/4 /201 6* FEI NUMBERBo t hell, WA 98021 3003429652(425)302- 03 4 0 Fax : (425)302- 0 4 0 4

NAME A ND TI'TLE OF INDIVIDUAL TO W HOM REPORT ISSUED

Ronald P . Du lwick , Owne r F IRM NAME STREET ADDRESS

Strohecker' s Pharmacy 1286 SE Holgat e Blvd C1 C ITY. STATE. Z IP CODE. COUNTRY

Po rt land, OR 97282 TYPE ESTABLISHM ENT INSPECTED

Produce r of St erile Produ c t s

10/4/1!J16

X Jeffery A Johnson Jeffery A Jal-nson Generic ()ug Use<FEe A~(<Dl.FA) sq>ed by: JeffreyA. Jal-nson · S

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE

Darren S Brown , I nvest igat o r Jeffery A Johnson, Generic Drug Use r FeeAmendment s (GDUFA)

X Darren S Brown

DATE ISSUED

10/4 /201 6

...........

FORM FDA 483 (09108) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 5 OF 5PAGES