district a.lldre8ij iinil phone hum8er 02/23/2016 · pdf fileindustry information ... policy...

DEPARTMENT OF HEALTH AND HUI't1AN SERVICES FOOD AND DRUG ADMIN!STRATIO'N

DISTRICT A.llDRe8IJ IINil PHONE HUM8ER

19701 Fairchild Irvine, CA 92612 (94 9) 608-2900 Fax : (949) 608-4417 Industry Information: www.fda.go v/oc/industry

""'"(e)ur-INSP""'"""

02/23/2016 - 03/14/2016* FCINUM8~

3003436217

NAME ANI) . ITI.E Of' INDIVIDUAL TO WtiOM RI!POR ISSUEO

TO : Nadia Mohame d Ibrahim Elsayed Ibrahim, Director of Operations/Pharmacist In Charge fiRMW<M£ Son""ti\UUKESS

South Coast Specialty Compounding , Inc. 9257 Research Dr CITY. STATE.ZIP CODE. COUNTRY TYPE ESTA!li.ISHMENT IN"""CTED

Irvine, CA 92618-4286 Producer of Sterile Drugs

This document lists observations made by the FDA rcpresentative(s) during lhe inspection ofyour facility. They arc inspectional observations, and do not represr.nt a final Agency determination regarding your compliance. Ifyou have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection ur action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above. ;

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate va lidation ofthe sterilization process.

Specifically,

A. Policy and Procedure Number 6.2.0 titled "Aseptic Technique Personnel Validation" is deficient in that it does not require the finn to perform media fill simulation with worst case scenario and does not address conducting media runs for the lyophilization process. For example,

a. Ascorbic Acid P-F Non-Com 500mglml injectable lot # : 112420 15@488 was made with batch size of [(~). (4 ) yielding!bH4l vials (non-steril~ to sterile production). Th e following table lists the media simulation ~~4) _::] not me~ting worst case scenario performed by personnel involved in sterile production.

I

Title Process mimic Media Lot Media volume #of vials (b)(6), lbll4) b)(4) (b)(7) Technician Non-sterile to :mt ·als ~ (C) Technician sterile ml vials

Technician ptl ~ials NI, Pharmacist ml vials

(b)(7) Technician ml C),(b) ~als~ (6) Techn ician ml ·als

Technician ml ~ials NI, Pharmacist 'ml ~ials

ViaLSize Date I

(b) (4)J

-4b. Artesunate Lyophilize~J,lowdr for Inj~ction 60mg per vial lot # 020420 16@2B was made wi ><> vial batch

size yielding bH4!) vialf, (7)(C). (b) echnician who has been maki,ng lyophilized products sincLc ~ til now has not perf~rmed meara m r testing simulating the lyophilization process. The first lyoplitltzed pro uct made by thel:l~c). [eclmician was Chorionic Gonadotropin - Hydro?_<.QQ~in Lyophilized Powder (5,000/2,500)

1).\fEIS&UEOEM PLOYEE(S)SIGW.TUR£ ~ /

Saied A. Asbagh, Investigator ~ ..., SEE REVERSE OF THIS PAGE

Binh T. Nguyen, Investigator ~ 03/14/2016Darren S. Brown, Investigator----~~

FORM JIDA 03(09/0S) PR£VIOUS EDmON <l8SOI.£nl INSPECfiONAL OBSERYA TIONS PAGE I OF9 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES

b.

EMPLOVEE(S)SIGNAlURE _.....-

Saied A . Asbagh, I nvestigator ~Kr· Binh T . Nguyen, Investigator t~

Darren S. Brown, Investigator ~(L_

PR.I!VIOVS EDmON 06SOWT1! fNSPECI'IONAL OBSERVATIONS

FOOD AND DRUG ADMINISTRATION DISlRICT ADDRESS AND PHONE MJMilCR

19701 Fairchild Irvine, CA 92612 (949) 608-2900 Fax: (949) 608-4417 Industry Informatio~ : www.fda.gov/oc/industry NAME ANDrnu: T ISSU EO

0ATI;(S) OF INSPECTION

02/23/2016 - 03/14/2016*

3003436217

TO: Nadia Mohamed Ibrahim Elsayed Ibrahim, Director of Operations/Pharmacist In Charge FIRM NAME

South Coast S ecialty Compounding , Inc. 9257 Research Or CITY, £TATE. ZIP CODE, C NTRV TYPE ElnAS~ISHM.ENT INSPECTE.O


U/mcg per vial lot# 1031201 5@1B exp 04/28116. Only one , pharmacist.Jl~onducted media fill simulation to mimic the lyophilization process as listed in th~T~<h e below :f~c~ Was not involved in the making of lyophilized products since about October 2015 whe (bJ <6J ta~ed making yophilized products.

B. Policy and Procedure Number 3.9.0 titled " LyoJ)hilizer Standard Operating Procedure!)" is deficient in that it does not address the b) (4 of the Lyophilizer ~(bf<41 ystems, Serial #(b)(4 Model# ~Jj. £er Nl. Pha!Jllacis ln-CharJ!.e (Pjg. t~ L..)!,Qohilizer is(bH41 b)(4)

)(4) The finn has not qualified the number of vials that can be processed in one run. The following table shows examples of all four lyophilized products made at the firm.

BUD Quantity Yield Vial size Product lot (b)\4) 0 I 08:20 16@54 B 6/11/2016 ,~Trimix #3 (Phent Jmg/papaverine 15 ~

mg/pge l 20 meg lyo sdv) (l/15)mg(20)mcg injectab le

(b)('l)J (b) ~Methyltetrahydrofolate lyophilized 20mg 7/6/:20160108~016@558 ~ injectable

Artisinate Lyophilized Powder 60 mg [b)(4) J8/2/Q016 ~02042016@2B .~ Injectable

'(ti)(4) 7/18/2016Chorionic Gon~otropin 0120f016@2B ~ ~

Hydroxocobalamin Lyophilized Powder (5,000/2,500)Uimcg injectable

* Batch record does not specify vtal stze. S1ze venfied by Drrector of Busmess Development.

c.

D.IITEISS

SEE REVERSE 03/14/2016OF THIS PAGE

FORM FDA 4IJ 09101) PAGE 2 OF9 PAGES

DEPARTMENT OF IlEALTil AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER

19701 Fairchild Irvine, CA 92612 (94 9) 608-2900 Fax: ( 94 9) 608-4417 Industry Information: www . fda.gov/oc/ i ndustry

DATE(S) OF INSPECOON

02/23/2016 - 03/14/201 6* PEl NUMBER

3003436217

NAME AND TITl.E OF INDIVIDUAL TO wnvM tu:>'U<T ISSUED

TO: Nadia Mohamed Ibrahim Elsayed Ibrahim, Director of Operations/Pharmaci st In Charge FIRMNAMJ:

South Coast Specia l t y Compounding , Inc . 8TREIIT ADDReSS

9257 Resea r c h Dr CITY, STATE, ZlP CODE, COUHTR'V

I r v i ne , CA 92618- 4286 TYPE I!STASCISHMENT ""SPECTEO

Producer of Sterile Drugs

OBSERVATION 2

Clothing of personnel engaged in the processing ofdrug products is not appropriate for the duties they perferm.

Specifically, Policy and Procedure Number 2.5.3 titled "Donning Sterile Garments" is deficient in that it does not state that forehead and neck areas should be completely covered. On 02/23/16, we obs.erve9~b)(4 employees working in the ISO 7 room with r'~o~ISO 5 hoods having partially exposed foreheadss:;;:Jechnician apd(b:~~C). echnician) and partially exposed neck are<~:~CJ. echnician only) while filling sterile Hepatin 1 ocaine 3300 ll';J/ml /265 mglml syringes (lot #02232016@2B) and~Yicobalamin 25mglml (Lot#l 2032015@2B) r~spectively. j . .

OBSERVATION 3

Aseptic processing areas are deficient regarding the system for mon itoring environmental conditions.

Specifically,

A. Policy and Procedure Number 6.5.0 titled "Environmental Monitoripg" is deficient in that

a. The firm does not perform environmental monitoring with active air sampling continuously during production of sterile drug products.

i B. Policy and Procedure Number 6.5 .1 titled "Giqved Fingertip Samplip.g" is deficient in tbat

I

b. "Daily Environmental Monitoring and [(6Jl.il)

Gloved Fingertie Sarn~g Program Log" states to ~6Jl"J~

r ~ 03/02116, we observed personnel sampling was performed on fmgertips (b)_(4 )

C. The firm follows Policy and Procedure Number 6.5 .2 titled "Glove/Sterile Gown Initial Qualification" to perform initial qualification ofoperators working on sterile drug products with no growth result as shown in the table below. This procedure does not require the firm to roll their fmgers from side to side.

a. Section 1 states "rTC't1 J' and d~s not require operators to roll fhe rrlll)gertips from sttle ~stde. rhts practice was observeel on 03/02/f6 during environmental monitoring ocffi4)

SEE REVERSE OF THIS PAGE

EMPI.OYEI:(Sj SIGNAlVRE

~Saied A . Asbagh, Invest igator Binh T. Nguyen, Investigator Darren S. Brown, Investigator ~4-- I

OATE"ISSUED

03/14/2016

FORM 11DA •83 (09/08) PREVIOUS IIDmON OllSOLI?m INSPECfiONAL OBSERVATIONS PAGE J OF 9 PA<)IlS

Initials, Title I Date Qualified I Date Qualified I Date Oualified Comment (b)(6), [Technician

'b' '4' No incubation temperature (b)(1)(C

Technician recorded irechnician NIA

NR • , Pharmacist No incubation temperature

~ recorded and same recorded (C). (b) Pharmacist ~ ) ~ ) date and time qualified (8)

*NK1S' he same emp oyee hstea as Nl-;-FJ~..-

DEPARTMENT OF H EAL T il AND I lUMAN SERVtC r..S FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER UA r t(S) OF INSPECTION

19701 Fairchi:J::d 02/23/2016 - 03/14/2016* Irvine, CA %:612 FEI NUMBER

( 94 9) 608-2900 Fax: (949) 608 - 4417 3003436217 Industry Information: www.fda.gov/oc/industry NAME AND TITI..£ OF INDIVIDUAL TO WoiOM REPORT ISSUED

I

TO : Nadia Mohamed Ibrahim Elsayed Ibrahim, Directdr of Operations/Pharmacist I n Charge FIRM NAME STREET ADDRESS

South Coast Special ty Compounding, Inc. 9257 Research Dr ClTY, STATE. ZIP COOE. COUNTRY TVPI! E81ABUSHMENT INSPECTED


OBSERVATION 4

The responsibilities and procedures applicable to the ql\ality control unit are pot in writing and fully followed.

Specifically,

A. SOP number 6.14.0 Titled "Particulate Testing for Sterile Drug Preparations" section IV.6 states that the inspector is to ~0><4> ] - · However, during the wa~ough on 2123120lp, we observed the inspector (Pharmacist) only visually inspecting Ascorbic Acid in amber vials (Lot# 022220 16@IB)(IJ) (4) J .

! '

B. There is no written procedtu'e other than! visual inspection prj:lcedure (6.14.0) to test for particulate matter for finished sterile drug products stored in amber vials after non-sterile to sterile, lyophilization, o:~ sterilized process. Per, NI , PIC, the firm switched most of the clear vials to amber vials approximately a (b) (4) ago.

EMPLOYEE(S) SIGNATUR£ DATE ISSUED

Saied A. Asbagh, Investigator ~SEE REVERSE Binh T . Nguyen, Investigator 03/14/2016OF THIS PAGE Darren s. Brown, Investigator ~ FORM F'I>A 413 (091111) PR.EVIOUS I!I>ITION OEISOLEI'E ,lNSPECiilONAL OBSE;RVATIONS PAGE 4 OF 9 PAGES

Preparat ion Product Lot # BUD Non-sterile to sterile EDTA Calcium Disodium PF 01272016@1B 7/25/2016

300mglml Inj ectable MIC-Bl2-B6 : Solution 020920 16@ 1 OB 4/9/2016 (25/S0/50/5/30)mg/ml injectable

MIC-B12-86-LCamitine (lipoden 01282016@7B 3128/20 16 plus) (25/50/50/5/50/50)mglml injectable Taurine 50mg/ml injectable 01272016@_38 4/26/2016

Lyophilized Chorionic Gonadotropin 01202016@28 7/18/2016 Hyd.roxycobalamin Lyophilized Powder 5,000!2,500) U/MCG TRIMIX #3 (Pbent 1 rug/Papaverine 01082016@548 6/11/2016 lSmg/pgeI 20rp.cg lyo sdv) ( l/15)mg(20)mcg inj ectable Metbyltetrofolate lyophilized 20mg 01082016@558 7/6/2016 injectable Artesunate lyophilized powder 60 mg 02042016@28 8/2/2016 i.rijectable

rb)(4) Sterili~e +t:i~tmsifleleae me'IEtfle'IEeeia 12152()15@418 6/122()16 SUSfleBSieB iajestieft (15/1) fft~IBI . . -·

Preparation Product Lot# BUD Non-sterile to sterile Phentolamine 0222016@62 417/2016

~(6)"(4) l 4MG/Pappvarine (~)_(4) j 30Mg/Atropirie 0.2 Mg

per ml inje~table Acetylcamitine 200 022220:16@51 417/2016 MGIML INJ Solution Injectable Hydrogen Peroxide PF 022220!16@41 417/2016 3% Injectable MethylsebaliJBiA 1~.5 ()2222916@34 417/21H6 MGffeliHis Asia 2§MGIMbP I" r .•

DEPARTME NT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMJN ISTRATION

OlSon"'' ~ANO-N\JMBER

197 0 1 Fairchild Irvine, CA 92612 (94 9) 608 2900 Fax: ( 94 9) 608-4417 Industry Inf ormation : www.fda . gov/oc /industry

DA"IE(S) Of INSPECllON

02/23 /20 16 - 03/14/2016* FfJ NVWeR

3003436217

NAME liND TITI.E Of INOIVJOUAL TO WliOM ~'• ""'\JED

TO : Nadia Mohamed Ibrahim Elsayed Ibrahim, Directdr of Operations/Pharmacis t In Charge.............., South Coas t Specialty Compounding , Inc.

STREfTAOORESS

9257 Research Dr CllY, $TATE, ZIP coco;, COUNTRY

Irvine, CA 92618-4286 lYPE fSTA8USHMENT IHSPECTED


C. The frrm does not have a written procedure on how to @ 4) whether products made are individual Wlits or a batch. Per DS, Director of Business Development, the firm normally ~bf(4) J l(bl (4 ) when the firm makes a batch. There is no documentation on the formula (orksheet to capture ~b) (4 ) The following__eroducts were

tllffi Iwas adeq_uate to protect product mtegnty:

1


EMPlOYE£($) SIGNATURE

~«Saied A. Asbagh, Inves,tigator Bi nh T. Nguyen, Invest;igator Darren S . Brown, Investigator ~,6

0.0.11: ISIIUED

03/14/2016

FORM FDA 4SJ (09108) PREVIOUS EDITION DOSOIJ!TE INSPECTIONAL OBSERVATIONS PAGES 01'9PAGES

:I

Phentolamine 022220 116@60 4/7/2016 1 MG/Papaveripe 30MG/PGE 1 1 Omcg per ml Injectable

Phentolamine 02222016@55 417/2016 I mglpapaverine 30mg!PGE 1 2QMCG per mllnjectable

ProstaglandineiE 1 100MCG Injec~ion

0222201:6@47 5/3012016

Solution Inject{lble

I

' I

: I

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

Specifically,

A. Policy and Procedure Number 4.1.0 titled "Clean Room, Cleaning, and Maintenance of' is deficient in that

a. Section B.3 under Cleaning Schedul~ states "Use bH4> ~wipes to clean counters, wqrk surfaces, scales and equipment." Per PIC~ ~used is non-steri e. :

b. There is no scientific rationale for the use of sporicidal cleaning agent, 11>> <4> 1 {b)(4 ) }Kb) (4_[ ) -

OBSERVATION 5

B. Policy and Procedure Number 3.9.0 titled "Lyophilizer Standard O~erating Procedure" is deficient in that it does not state

a. whether )(4) and~ -1 are sterile - in actual practice, the fum used non-steril b)(4) -~ per the Director of Corporate Development

b. the lyophilizer cleaning l~g only documents the use of the ~bl C4l 1and no\!b> C4l 1

c. the location ofcleani ng (ISO 7 or non-classified area) where the lyophilizer is to be cleaned

I

DEPARTMENT OF HEALTH AND H UMAN SERVlCES FOOD AND DRUG ADMINISTRATION

DISTRICT AOORESS AND PHO>E NUMBER

19701 Fairchild Irvine, CA 92612 (949) 608-2900 Fax: (949) 608.- 4417 Industry Information: www.fda.gov/oc~industry

OATE(S) OF II'ISPECTION

02/23/2016 - 03/14/2016* FEINUMBER

3003436217

NAME AND Tilt£ OF INDIVIDUAL TO \'MOM REPORT ISSUED

TO: Nadia Mohamed Ibrahim Elsayed Ibrahim, Directd,r of Operations/Pharmacist In Charge fiRM 'NAME

South Coast Specialty Compounding, Inc.

STREETADORESS

925 7 Research Dr CITY, STATE, ZIP C00E. COUN1RY

Irvine, CA 92618-428 6 lYPE ESTABI.ISHMEHT INSI'ECTEO

Producer o f Sterile Drugs


EMPWYEE(S) SIGNATVRE

-?trSaied A. Asbagh, I nves tigator Binh T. Nguyen, Investigator gJ Darren S. Brown, Investigator ~

DATE ISSUED

03/14/2016

IIORM FDA 483 (09/01) I'!UlVIOIJS EDmON OIIS()iET1l INSPECTIONAL OBSERVATIONS PAGE 6 OF9 PAGES

I •

I

I

~ '

I

1

I

I!

I I

EMPl.OYI5E(5) SIGNA T1JR£ DATE ISSUED

Saied A. Asbagh, Investigator 5I}-Binh T. Nguyen, InvestigatorSEE REVERSE ~ 03/14/201 6 Darren S . Brown, InvestigatorOF THIS PAGE IS"-6

FORM FDA 483 (09/08) PREVIOUS EDITIONOBSOlETe INSPECflONAL OBSE RVATIONS PAGE 7 OF 9 PAGES

II

DEPARTMENT OF HEALTH AND RUMAN SERVICES FOOD AND DRUG ADMINISTRATION !iOISmiCT AOORES$ ANO PHONE NVMBER DATE(S) OF INSPECTION

19701 Fairchild 02/23/2016 - 03/14/2016* FEIN\IMIJERIrvine, CA 92612

(94 9) 608-2900 Fax:(949) 608-4417 3003436217 I ndustry Information : www. fda. gov/oc/i ndustry NAMEAND Tm£<l' INOMOUAI. TOV\tiOM RB'OftT ISSUED

TO: Nadia Mohamed Ibrahim Elsayed Ibrahim, DirectQr of Operations/Pharmacist In Charge 'IRMNAMI: 8TREt1 AllOR"""

I• South Coast Specialty Compounding, Inc. 9257 Research Dr CITY, STATe, ZIP CODE. COUNTRY TYPE ESTAIR ISHMENT INSPECTeD I• Irvine , CA 92618-4286 Producer of Sterile Drugs

Per the Nl, PIC, this section applies to cleaning ofthe inside and outside ofthe lyophilizer.

c. The firm has not conducted cleaning validation studies of the :<ID14 } _] non-sterile dmg products such as Ascorbic Acid and Heparin/Lidocaine. The f:irn.1 also has no written cleaning procedure for the cleaning ofthe Kbl(~ l , T~ cJeaniniU>Lthe(b_ll4l ] is docujnented on a cleaning log titled "Sanitary ~bT(4>l

1141 - Cleaning Log" w1tll,'" J

OBSERVATION 6

There was a failure to handle and store drug product co~tainers and closures at all times in a manner to prevent contamination.

Specifically,

Policies and Procedures 3.3.1 titled "Vials,j(b) (4 ) Js 3.3.2 titled "Glassware for Sterile Compounding- (b)_(4) J and 3.3.3 titled "r' '~' Stoppers - (b) (4) J r ---, are deficient in that

I •

A. The sterilized vials and stoppers are stored in~6ll"1 rodu~tion area for future use as needed without any 41expiration or end of use date. On 02/23116. we observed sever.al [bf( Jvials and stopper bags labeled

"sterilized" were stored on shelves situated ~141 production area.

B. No hold-time studies have been conducted to assure sterility of the container I closure systems. For example, vials which were used to produce the following products had t he followirlg hold-times.

f{b) (4)Product Container/Closuie tJ?lr~o Triamcinolone I Vial Moxifloxacin lnj TS Stopper I Lot# 02092016@608

l(b)(4 ) Phentolamine I Prostaglandin Vial }--Lyo Stopper L Lot# 02112016@68

lb)(4)Taurin lnj Vial Lot# ll232015@46B Stopper L J

I I

I

DEI'ARTMENTOFHEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTR.AT[ON

OI!>TRICTAOORESS AND PHONE NUMBER

19701 Fairchild Irvine, CA 92612 (94 9) 608 - 2900 Fax : (9 49) 608-4 417 I ndustry I nformation: www.fda.gov/oc/industry

DATE(S) OF INSPECTlON

02/23/2016 - 03/14/2016* FEJNUMBER

3003436217

NAME AND 'frrLJ! Of' INOM()UAI. 1'0 WHOM HI'I"<JKl IIISOJI!O

TO : Nadia Mohamed Ibrahim Elsayed Ibrahim, Directcpr of Operations/Pharmacist I n Charge FIRM NAME

South Coast Specialty Compounding , Inc . STREETAOOR£SS

9257 Research Dr CITY. STIITE.ZJP CODe, COUNTRY

Irvine, CA 92618-4286 TYPe ESTABI.I-~l{TINSPECTEO


OBSERVATION 7

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.

Specifically,

A. The firm bas no written procedure to describe the number of items allowed to be placed in ISO 7 filling room. On 02/23116, we observed this ISO 7 fill ing room to have (t>) (4) ] four carts full of bags, containers on the AOOf shelf, and equipment while'(lil (4) technicians were working.

B. On 02124/16, we observed the double~doors in the back :of the facility have gaps at both the bottom (approximately 1/2 inch) and top (approximately 1116 inch) of]the door when they are closed. One of the doors was not tightly shut and the rolling do~r was also not shut.; The double door is located between the nonclassified production area and an exterior:metal roll up door. ·

C. On 03102/16, we observed a s ingle door iii the back of the facility had been kept open using a door stopper.

D. There are one restroom and one break room located in the 1main production area where personnel wearing scrubs and shoe covers throughout the day can enter restroom and break room and then go back into sterile production area where sterile gowning is not completely donne~.

OBSERVATION 8

Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

Specifically, the pH meter used to measure the product pH has been calibrated b 4 pH levels, i.eKt>H 4 ) J The following products, however, were tested outside the calibrated range:

A. in/L'd . I I l 0 @ Hf6ll"'lHepar 1 ocame, 1 11 16, ot no. 01112 16 558, p B. Poly-MY A solutio~ l/8/16, lot no. 01082016@18, pHP»H"J] c. Folic Acid solution, 9/17/ 15, lot no. 09172015@27B, p '(6f<ll


EMPLOYEE(S) SIGNAlURE

Saied A. Asbagh, I nvestigator ~ Sinh T. Nguyen, Investigator Darren S . Brown, Invest igator ~

DIITE 18SUED

03/14/2016

FORM FDA 413 (09101) PIU!YIOUS EDmON OllSClt.EIE INSPECTI ONAL ODSERVA TIONS PAGE 8 Of 9 PAGES

DEPARTMENT OF HEAI~TH AND IIUMAN SERVICES FOOD AND DRUG ADMrNISl"RATION

DISTRJC T ADDRESS AND PHONE NUMBeR DATE(S) OF INSPECTION

1 9701 Fai r chi l d 02/23/2016 - 03/14/2016* FEl NUMBfRI r vi ne , CA 92612

(9 4 9 ) 60 8-290 0 Fax: (949 ) 6 08 -4417 3003 436217 Indus t ry I nformation: www.fda .gov/ oc( industry NAME AND T~OF INDIVIDUAL T OWtOM REPORT ISSUED

TO: Nad i a Mohamed Ibr a h im El sayed I brahim, Director of Operat ions/Pharmacist In Charge A RM NAME

South Coast Specialty Compounding, Inc . CllY, STAll:. U' OOOE, COUNTRY

Irvi ne, CA 92 61 8- 4286

Snu:ETADORE""

9257 Res~arch Dr lYPE EST ABUSHME!fT INSPECTED

Producer . of Sterile Drugs

*DATES OF INSPECTION: 02nJ/2016(Tue), 02/24/2016(Wed), 0212512016(Thu), 0212612016(Fri), 0212912016(Mon), 03/0 112016(Tue), 03/02120 l6(Wed), 03/0412016(Fri), 03/07/2016(Mon), 03/08/2016(Tue), 03/09i2016(Wed), 03/ ll /20I6(Fri), 03/1412016(Mon)


EMPlOYEE(S) SIGNATIIRE

Saied A. Asbagh, I n ves t: igato~r:;..Binh T. Nguyen , Investigator Darren S. Brown, I nvestigator

w-/· ) _.~......t~,....;;~;,:~:::~-f/S:======-~ -~~ ~

DATE ISSUED

03/14/2016 ~,~~-

FORM FDA W (0911)8) PREVIOUS EDmO~OllSOU!Jll lNSPECTIONAL OBSERVATIONS I'AGE90F9 PAGBS

district a.lldre8ij iinil phone hum8er 02/23/2016 · pdf fileindustry information ... policy...

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