SEE REVERSE OF.THIS PAGE

EMPI..OYEE(Sl SIGNA1lJRE

~~ ~(/!?~

DATE ISSUEDEMPLOYEE(S) NAME AND TITLE (Piint orType}

Anita Na:rula, Ph.D., CSO Nancy E. Byerly, CSO 03/08/2017Gacy C. Pecic, Microbrologist LisaT . Michel, Microbiologist

FORM FDA 483 (9108) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT OFFICE ADDRESS AND PJ:!ONE NUMBER

US Food and Drug Administration, 22215 26th Avenue, Suite 210 Bothe11, WA 98021 Phone:42S-302-0340 Industly Infonnation: www.fda.gov/oclindustrr

OATE(S) OF IN~EC710N

1/26/2017-3/8/2017

FEJ NUMBER

3006089725

~E AND un.E OF INDIVIDUAL TO.'M10M REPORT IS ISSUED

_TO: Mrs. Hee Joo Park, RPh, President and CEO, COO, CFO FIRM NAME

Puget SoWid Drug Corporation dba Key. Compounding Phannacy

STREET ADDRESS

530 South 336th Street CITY. STATE AND ZIP COOE

Federal Way, WA 98003

T'YPE OF ESTABUSHMENT INSJ>ECTEO

Producer ofsterile and non-sterile drug products

'THIS DOCUMENT USTS OBSERVATIONS MADE BY THE_FOA REPRESENTATIVE(S) DURING 'THE INSPECTION OF YOUR FACIU1Y. THEY ARE INSPECTIONAL OBSERVATIONS; AND 00 NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN OBSERVATION, OR HAVE IMPI..EMENTED, OR PLAN TO iMPLEMENT CORRECTIVE ACTIO!\! IN RESPONSE TO AN OBSERVATION, YOU MAY DISCL!SS THE OBJECTION OR ACTION WITH THE FDA REPRJ:SENTATIVE{S) CURING Ttil: 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 (I) (WE) OBSERVED:

OBSERVATION 1 Actionable microbial contamination was present in the ISO 5 ,area or in adjacent areas 9uring aseptic production without adequate product evaluation and remedial action .

Specifically, Your fmn recovered following objectionable mictoorgani$ms from the classified areas and failed to conduct a riskfl.Dlpact assessment o~ the products produced and distributed from November 2016 to Fehruary 2017. During this time when objectionable microorganisms were recovered from your facility, approximately 41 llll\ batches of sterile drug products were produced in the ISO 5 hoods from 1125/17 to 2/28/17.

A Microorganisms recovered from the ISO 5 hoodsi 1) On 1/26/17, in-house surface samples collected from the (b) ( 4) J showed 5 colony fonning units (CFUs) per plate from the._ _i5 )J.4l J and 4 CFUsper plate from the -(15) (4)1 (total9· CFUs). Bacillus homeckiae was identified from these surface samples.

I

2) Additionally, Bacillus homeckiae was reoovered from in-house surface samples collected on 1/26117 from

th~ l I (2 CFUs per plate) and from the (15 (4) f (5) (4) 1on 1/2~117 (1 CFU per pbt.te from the (b)(4) and 1 CPU per plate ~om the[ (15) (4) ]

the

B. Microorganisms recovered from the I (5) (4) j are located: 1) On 1/12/17, viable air samples collect~ from the' (b) (4) 1· sho~ed 3 CFUs·ofgram positive cocci and I CFU ofMicrococcus spp. during environmental sampling by your third party contractor. 2) On 11/15/16, viable air samples collected ~m the (15) (4) showed presence of Aspergillus niger (1 CFU),non-sporulating . ~gi (3 CFUs), Penicillium (5 ~s), Cladosporium (1 CFU), Staphylococcus co~gulase (-) (4 CFUs). .

and r

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DI STRICT OFACE ADDRESS AND PHOI'E NUMBER

US Food and Drug Administration, 22215 26th Avenue, Suite-210 Bothell, WA 98021 Phone: 425-302-0340 Industry Infonnation; www.fda.gov/oc/industry NAME AND TITLE OF INDMDUAL TO INHOM ~EPORT IS ISSUED

TO: Mrs. Hee Joo Park, RPh, President and CE05 COO, CFO' F.IRMNAME

Puget Sound Drug Corporation dba Key Compowtding Pharmacy CITY, STATE AND ZIP CODE

Federal Way, WA 98003

OATE(S) OF INSPECTION

1/26/2017-3/8/2017

FEINUMBER

3006089725

STREET ADDRESS

530 South 336tJ, Street iYPE OF ESTABUSHMENT INSPEC1ED

Producer ofsterile and non-steriie drug products

EMPLOYEE(S) SIGNATURE

SEE .EMPLOYEE{S) NAMEAND llnE(Ptint orType) DATE ISSUED

A.:J#. {Up~ AnitaNarula, Ph.D., CSO RJ:VERSE

./}?~~~~~ Nancy E. Byerly, CSO ' OF THIS 03/08/2017

PAGE Gary C. Pecic, Microbiologist Lisa T. Michel, Microbiologist

FORM FDA 483 (91081 PREVIQUS EDmON OBSOLETE JNSPECTIONAL OBSERVATJONS Page2of7

OBSERVATION 2 Aseptic practices are deficient regarding the system for cleaning and d~infecting the room to· produce aseptic conditions.

Specifically, A. On 01/26/17, the Pharmacy Technician used a small stainless. ~teel hand-held mini mop with a sterile cleaninpad. The technician soaked the cleaning pad with sterile (15) (4 ) ] and sanitized the walls ofthe [(l5) (4 )J ISO 5 hood. After cleaning, the tecbitician hung the mop with a dirty cleaning p~d inside the hood and filled a sterile injectable drug, TriMix, lot# 01-25-2017@10. The technician completed the sterile filling process, cleaned the ISO 5 ho.od and did not remove the dirty mop from the hood.

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B. On 01/26/17, the Pharmacy Technician failed to clean the ceiling and return grates ofthe [(1:5) (4 )1 ISO 5 hood with sterile [ (15) (4) } before or after the production ofTriMix, a sterile injectable drug product, lot# 01-25-2017@103. Yo\il," current practice is to clean these surfaces ofthe ISO 5 hood I (D) (4) 1 during (D ) (4) Icleaning.

C. On 10/24/16, during I (1:5) (4 ) 1 cleanihg that included cleaning ofall surfaces (wall, floors, ceilings, etc.) ofthe ISO 5, ISO 7 and ISO 8 areas, your firm used [ (15) (4) ] that bad expired on9/17/1~.

D. Your SOP 3.02 titled: Cleaning Maintenance ofthe Clean Room Facility, reqriires you to performt(D) (4 )] cleaning with I (D) (4 ) Isolution. According t6 your cleaning logs, I (D) (4) 1wasmade [ (1:5) (4 ) !

(D) (4) 1 Your firm a5signed _i5)J4) j expiration to L1DU 4)_ j There is no docwnentation that [ (15) (4 ) ] was made for the [(o) (4)J cleaning and· that the work surfaces· in the ISO 5, ISO 7 and ISO 8 areas were cleaned with ((b) (4~ e~ery~ in November and December2016, ~required by your SOP. Addi~onally, your SOP does not specify .tlie·exposure time ofthe contact surface with .the cleaning/disinfecting solution.

and

E. On 02/22/17, we observed that the.Pharmacy Technician was using non-sterile wipes for disinfecting work surf~es in the f{ 5JT4JUSO 5 hood.durlng,produ~tion ofa' sterile injectable, Hydroxo B-12 PBF, 5 mglmL MDVINJ, lott02-21-2017@lll.

SEE R£VERSE OF THIS PAGE

EMPLOYEE{$) SIGNATURE

.L:J;~

./)1~~~

EMPLOYEE(S) NAMEAND TITLE (Print Or Type)

Anita Narula, Ph.D., CSO Nancy E. Byerly, CSO Gary C. Pecic, Microbiologist Li~T. Michel, ~crobiologist

DATE ISSUED

03/08/2017

FORM FDA 483 (9108) PREVIOUS EDITION OBSOLETE INSPECTIONAI.. OBSERVATIONS Page3of7

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOOAND DRUG ADMINISTRATION

DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION

US Food and Drug Administration, 22215 26th Avenue, Suite 210

1/26/2017-3/8/2017

Bothell; W A 98021 FEINUMBER Phone:425-302-0340 Industry Information: www.fda.gov/oc/industry

3006089725

NAME AND Tm.E OF INOIVIOUALTO 'M-IOM REPORT IS ISSUED

TO: Mrs.Hee Joo Park, RPh, President and CEO, COO, CPO FIRM NAME

Puget Sound Drug Corporation dba KeyCompounding Pharmacy

STREET ADDRESS

530 South: 336th Street CI'TY, STATE AND ZIP CODE

Federal Way, WA 98003

TYPE OF ESTABLISHMENT INSPECTED

Producer ofsterile and non-sterile drug products

F. Your SOP 3.02 titled: Cleaning and Maintenance ofthe Clean Room Facility, states that the [ (1:5) (4 )] cleaning will be done with [ (o} (4} However, forthe r<oH 4 >l cleaning

· p~rfonned on [ (1:5) (4)] and [(15) (4)], the disinfecting solutions were not [(l:>) (4~ aod0C o) (4 )] was used [ (1:5) (4 ) ]for [ (15)(4) I

OBSERVATION 3 Envin~nmental monitoring is not ade(pmtely perfonned in your aseptic areas.

Specifically, your firm performedfli5} (4Jl cleaning and collected environmental samples approximately withinE ofcleaning. For example:

A. Your firm performed 1 (o) (4 )t cleaning on 3114/16 and in-house surface samples for environmental monitoring were collected on 3/15/16.

B. Your finrt, performed [ (l:>) (4 )] cleaning on 1/11/17 and· surface samples for environmental monitoring were collected by your third· party contractor on 1/12/17.

OBSERVATION4 There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. ·

Specifically, your finn failed to conduct adequate investigation regarding sterility assurance ofa sterile drug product. On 11/3/16, your firm produced Sodium Phenylbutyrate, Lot ill-02-2016@87 that failed sterility when sentto an outside testing laboratory. The same lot ofSodium Phenylbutyrate, Lot tll.-02-2016@87, when tested in-house, passed the sterility test. Your firm opened an investigation, Internal Quality Related Event (QRE) on 01/04/17 approximately tWo·months later. However, the investigation failed to identify a possible root cause and the potential discrepancy between sterility test resu~ts for the in::house . testing and outSide testing laboratory.

'

OBSERVATIONS Aseptic practices are deficient regarding the system for maintaining an environment suitable for production of .sterile drugs.

DEPARTM~NT OF HEALTH AND. HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT OFACE ADDRESS AND PHONE; NUMBER

US Food and Drug Administration, 22215 26th Avenue, Suite 2-10 Bothell, W A 98021 Phone:425-302-0340 Industry Information: www.fdagov/oc/industty

OATE(S) OF INSPECTION

1/2612017-3/8/ 2017

FEINUMSER

3006Q89725.

NAME AND TITLI: OF INDMDUALTO WHOM REPORT IS ISSUED

TO: Mrs. Hee Joo Park, RPh, President and CEO, COO, CFO FIRM NAME

Puget Sound Drug Corporation dba Key Compounding Phannacy

STREET ADDRESS

530 South 336th ,Street CITY, STATE AND ZIP CODE

Federal Way, WA 98003

TYPE OF ESTABliSHMENT INSPECTED

Producer of sterile and non-sterile drug products

SEE. REVERSE OF THIS PAGE

EMPLoz::g:GNATURE. -~ /11~[1~

EMPI..OYEE(S) NAME AND TITLE(Print or 'l)pe)

Anita Narula, PhD., CSO Nancy E. Byerly, CSO Gary C. Pecic, Microbiologist Lisa T. Michel, Microbiologist

DATE ISSUED

03/08/2017

FOR~ FDA 483 (9/08) .PREVIOUSEDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page4of7

Specifically, A. On 2/22/17, we observed· various examples ofpaper and cardboard, stored and/or. in use, in the ISO 7 "Compounding Room", to include card board boxes containing (15) (4 ). and a small sign with the Key Compounding Pharmacy name and logo on it

B. Additionally, on 2/22/17 we observed the Phannacist Technician and the Lead Pharmacist exchanging a paper note pad back and forth through the (5) (4) 1 where the Pharmacy Technician was observed writing Jlli:xr~ uests for supplies on the note pad while it was in the I (5 ) (4) ] . The Pharmacy Technician remained in the ISO 7 "Compounding Room" and the Lead Pharmacist was in the ISO 8 ·~Prep Room". We obserVed this practice 4-S tiliies within· the eourse ofapproximately 20 minutes.

OBSERVATION 6 Personnel performing aseptic operations failed to disinfect or change gloves frequently enough to prevent contamination.

SpecificaJly, A. On 1/26/17, the Pharmacy Technician donned sterile gloves on top ofnon-sterile gloves. After sanitizing the I(5 ) (4)I ISO 5 hood an4 f (5) (4J .I etc., the technician did not disinfec()(6~(tiX7sterile gloves and started[ (5) (4 ) ] a sterile injectable drug product, TriMix, lot# 01-25-2017@103 f5 4H j

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I

B. On the following occasions microorganisms were recovered from the sterile glove fingertips ofthe Pharmacy Technici~ involved·in producing sterile drugs: (b)(6~(b) •

1) On 1/25/17, 1 CFU was recovered from the " H4lfingertip ofthe techniciartt::..Jrbe microorganism identified was Bacillus benzoevorans.

1~) On 1/26/17,1 CFU was recovered from tb 'CbH:.ti fingertip and 2 CFUs from the (b) (4)fmgertip ofthe technician, (bm-d:') The microorganisms identified from the(b) ( 4) fingertip were Bacillus horrieckiae. The to> 4< ffingertip results were examined visually by your consultant microbiologist and the microorganism was considered as spreader,

Bacillus. · _p6~~'!'ll.,3) On 1/27/17, 1 CFU was .recovered from the(b) (4): fingertip ofthe technician;~arnple was sent to (o) (4 )

:

DEPARTMENT OF HEAL1H AND HUMAN SERVICES FOOD AND DRUG ADMINiSTRATION

DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSP~ION

US Food and Drug Administration, 1/26/2017.; 3/8/2017 22215 26th Avenue, Suite210 Bothell, WA 98021 FEINUMBER Phone: 42S.302-Q340 Industry Information: www.fda.gov/oclinduslry

3006089725

NAME AND TITLE OF INDIVJDOALTO WHOM REPORT IS ISSUED

TO: Mrs. Hee Joo Park, RPh, President and CEO, COO, CFO FIRM NAME

Puget Sound Drug Corporation dba Key C~mpoundingPharmacy

STREET ADDRESS

530 South 336th Street CITY. STATEAND21P CODE

Federal Way, WA 98003

TYPE OF ESTABLISHMENT INSPECTED

Producer ofsterile and non-sterile drug products ...

SEE REVERSE OF THIS

PAGE

EMPLOVEf<S) ~IGNATURE

WA~

/)1~~

EMPLOYEE(S) NAMEAND TITLE (Print orTypo)

Anita Narula, Ph.D., CSO Nancy E. Byerly. CSO Gary C. Pecic, Microbiologist Lisa T. Michel, Miaobiologist

DATe ISSUED

03/08/2017

PORM FDA 483 (9108) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page5of7

(5) ( 4) ] for microbial identification. lbd/.(bQn 2/2/17, 1 CFU was recovered from the(b> 4< >fingertip and 1 CFU from th (b ) (4). fingertip ofthe tec4nician,

(c) 'Your firm discarded these samples and no microbial identification was performed. ·

OBSERVATION 7 The final containers/closures used for drug products intended to be sterile have not been sterilized or depyrogenated.

Specifically, there is no assurance that the container and closures that undergo in-house sterilization or depyrogenation are sterile, as follows:

A. Your firm did not use [ (6) (4) ~with every.. batch ofcontainers and closures that are sterilized in-house using [ (b) ( 4) . Tbe (b)(4~are used [ (b) (4) ~:.Also, there is no documentation about the I (5) (4) lwhei(b> (41

were used.

B. Your ftrm failed to assign any batch identifiers and did not establish hold times for containers, closures and all re-usable sterilized equipment, after l (b) ( 4) Jand/or depyrogenation.

C. There is no data to support the continued sterility ofvarious sizes ofamber-colored glass vials such as 2mL, SmL, 1OrnL, 20mL, 30mL and SO mL that undergo in-house sterilization and depyrogenation.

D. There is no data to supportcontiD.ued sterility ofthe [ (b) (4) Jstoppers th~undergo in-house sterilization.

OBSERVATION 8 Inadequate pressure differential~ betWeen lower quality air rooms and higber·quality air rooms were observed.

Specifically, on 1126/17 we observed inadequate pressure differentials between the ISO 8 Ante Room lower quality air room and the higher quality air in the ISO 7 "Compounding Room". Also, the air pressure differential between the unclassified non-sierile oompounding area into the ISO 8 "Prep Room" were apparently not workingThe following issues were not~:

'

DEPARTMENT OF HEAL.TH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT 9FFICE ADDRESS AND PHONE NUMBER

US Food and Drug Administtation, 22215 26th A venue, Suite 210 Bothell, WA 98021 Pbone:425-30~0340

lndustty Jnfonnation: www.fda.gov/oc/industty

DATE(S) OF INSP~ON

1/26/201-7-3/812017

FEINUMBER

3006089725

NAME AND TITLE OF INDIVIDUALTO VMOM REPORT IS ISSUED

TO: .Mrs. Hee Joo Park, ~h, President and CEO, COO, CFO FIRM NAME

Puget Sotmd Drug Col],oration dba Key C0mpoun4ing Pharmacy

STREET ADORESS

530 South 336th Street CITY, STATE AND ZIP CODE

Federal Way, \VA 98003

TYPE OF ESTABUSHMENT INSPECTED

Producer ofster.ile and non-sterile drug products

SEE REVERSE OF THIS PAGE

EMPLO"YEE(S) SIGNATURE

Av:J;~

t/)1~~

EMPLOYEE(S) NAME AND Tm.E (Ptfnt or 'l)lpe)

AnitaNarula, PhD., CSO Nancy E. Byerly, CSO Gary C. Pecic, Microbiologist Lisa T. Michel, Microbiologist

DATE ISSUED

03/08/2017

FORM FDA 483 (9108) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Paae6of7

A. The Magnebelic gauges did not appear to be registering movement ~dwe did not feel any pressure difference enteritig in or exiting out ofthese rooms. Your firm had issues with the airpressure dif(erential since 2015 as evidenced by your HVAC contractorO o) (40 Invoice# (6} (4), dated 5/18/15 which states that the "clean room side robing in the wall was pinched and folded over itself' and that ''the lab side [(5) ( 4~was not engaged fully on

· the brass barb". Additionally, L _(~U4) JWork Order# (D) (4) .I' dated 9/13/16 states that the "pressure in the clean:foom is too low and the belt for the HEPA is making some noises".

B. On 1/26/17, 1127/17 and 1/30/17, your finn recorded the air p~ssure for the Ante Room as 0.01 psi which was below the acceptable value o~lbll4~ psi for the Ante Room as per your (b ) (4) monitoring record. Your ftrm continued producing sterile drug products during this time when there were issUes with gauges and/or air pressuredifferentials.

OBSERVATION 9 Equipment and tools used are not ofapl?ropriate materials for in sterile drug production. use

Specifically, on 1/27/1.7, dur:ing non-sterile to sterile production ofa sterile ophthalmic solution, AtrQpine sulphate 0.5%, lot tO1-26-2017@93, we observed that the Pharmacy TechniCian I (o li4 )~ ,atropine sulphate in a {~). (4 )1 hood using wooden {~). (4 }J that is particle generating and dlfficultto clean : This wooden [(o)_(4 ) had visible scratches which do not aUow the [(5) (4~ to be cleaned properly.

OBSERVATION 10 IS0•5 classified areas were not certified under dynamic conditions.

Specifically, smoke studies have not been performed in the ISO 5 hoods under dynamic conditions sin~O)l4Jl

OBSERVATION 11 Highly potent drugs were produced without providing adequate containment, segregation, and/or cleaning ofwork surfaces, utensils, and/or personnel to prevent cross-contamination.

Specifically, your firm handles potent dru~ substances including hormones and :there are no procedures or controls

DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION

DISTRICT OFFICE ADDRESS AND PHONE NUMBER

US Food and Drug Administf11tion, 22215 26th Avenue, SUite210 Bothell, WA 98021 Phone: 425-302-0340

Industry Information: www.fda.gov/ocfwdustry

DATE{ S) OF INSPECTION

1/26/2017-3/8/2017

FSNUMBER

3006089725

NAME AN~TITLE OF INDIVIDUAL TO.'M-IOM REPORT IS ISSUED

TO: Mrs. Hee Joo Park, RPh, President and CEO, COO, CFO FIRM NAME

Puget Sound Drug Corporation dba Key Compoun~g Phannacy

STREET ADDRESS

530 South 336th Street CITY, STATE AND ZIP CODE

Fe.deraiWay, WA 98003 .

lYf>EOF ESTABUSHMeNT INSPECTED

Producer ofsterile and non-sterile drug products

FORM FDA 483 (9108) PREVIOUS EDITION OBSOlETE INSPECTIONAL OBSERVAnON_S Page7of7

in place to prevent cross-contamination. On 2/1/17, we observed following issues related to the control and potential cross-contamination ofhonnona1

I

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substances in th~. (o) ( 4) l.hoods in the •< non-sterile area:

I

A. After filling the Progesterone EYM 60mg capsules, lot 1-27-2017@1OQ, the Pharmacy Teclmician was · observed cleaning the equipment by blowing air on the equipment. This resulted spreading of the hormone,.,[[ (lo)oc-c.--(""4"'-)1 dust all over the hood. During production ofnon-sterile Progesterone EYM 60mg capsules, Jot 1-27-2017@100,

1l 6)l4Jldust accumulation was observed in the boo~ on the pre-filters {before HEPA filters), along the seams of · thehoods.

B . The Pharmacy Technician did not clean th~ ceiling ofthe hood as part of (l>~)post;.production cleaning OP.erations. The hood interior ceilings are cleaned only during f{6)(4n cleaning. There were visible particulate residues remaining in the hood after cleaning and proceeding to the next batch.

· C. Additionally, the hood was wiped down with a wipe soaked wi (1:5) (4) followed by cleaning with [ (1:5) (4 ) ] before proceeding production for the next batch ofthe drug product. However, your fum dOes not have data to 'support that cleaning witb (D) (4 ) ] and[ (D) (4 ) ]..will effecti.vely neutralize potent drug residues.

D~ The technician's sleeves were observed contacting (D) (4)1 residues on the Hood #l bench surface during capsule filling of Progesterone EYM 60mg capsules, lot 1-27-2()17@100. The technicians use the same lab coat for ilppro~ately [(D) (4 )]:. The lab,coats are not changed between batches ofvarious highly potent drugs products produced.

SEE REVERSE OFTHJS PAGE

EMPLOYEE(S) SIGNATURE

L.:.J;~

--71~~~

EMPLOYEE(S) NAME AND TITLE (Ptillt orTwa}

ADita Narula, Ph:D., CSO Nancy E. Byerly, CSO Gary C. Pecic, Microbiologist Lisa T. Michel, Microbiologist

DATE ISSUED

03/08/2017