DEPARTM,'\1 OF HEALTII Al\1) llljman.servic 5 FOOD AND DRUG ADMINIS1'RATION 01\Tt'{S) Of' IMi!'I!CT!ON

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1 ,. s_ Yll"f.i.. ~. ~:. -~. OIS1Rier -~.\110 PHO>" <51>~ DEPARTM,\1 OF HEALTII Al\1) llljman.servic 5 FOOD AND DRUG ADMINIS1RATION 01\Tt{S) Of IMi!I!CT!ON 404 BNA Dr., Bldg. 200, Ste /15/ fi:inum!iitr NashYille, TN J (615) Fax : {615) Industry Information: gov/oc/industry NJ.ME AN!) 1Jli.E( a I>I!:AVIOU.ll. to VI!IOM RF.I>ORT l$tioo TO: Dr. Rickey L. Chance, President /Otmer.. fl16.! WJ.lf Sn<H7AOO.U,ss Coastal f-1e ds, LLC Medical Park Dr., Suite C Cl. Sl klc. Z!I cocti, IOOUN l lly """lii(j;ra$us><~jv<r,,....,tier!> Biloxi, f-1s outsourci~1g Facility 1llis oocumentl isls ob$.l!rvations made l>y rhe FDA rcprcsentativc{s) during the inspection ofyour facili ly. They are inspectional observations,!md do not represent a finn! Agency determination regarding your compliance. If you h<wc an objection regru-diog an observation, or have implemented, or plan to implement, correc1ivc action in response to an observation, ;Ou may diseu:.s the objection or a<:tion with the FDA representatlve(s) during the inspec1ion or submia this inform<llion to FDA at the address above. If you have any questions, please contact FDA at ahe phone number and address above OURING AN INSPECTION OF YOUR FIRM t OBSERVED: OBSERVATION 1 Aseptic processing areas arc defic.ient regarding the sysc.em for monitoring environmental conditions. a) Surface and air monitoring is not perfonned of the ISO 5 enviwnmenl (room and laminar Oow hood) e-ach day slerik drug products are produced. As stated i.n your procedure, , Air and Surface Sampling," Air sampling for vinble and non-viable ~organism..s (bacterial and fungal) shall be performed on a H:i) (4) basis". b) Pressure differentials are nor monitore<l between the ante room (tso 7) and the clean room (ISO 5) and betwee n the ante room (ISO 7) and the non-classified area due to the absence ofpressure gauges. Your procedure, , Cleanroom and Anteroom Activities and Specifications, states p[ o) (A} ~b)(4 ) 1 c) There is no evidence to show airflow has constant pressure in the ante room with sink located just outside the clean room (ISO 5). d) Certification of the ISO 5 environment docs not occur under dynamic conditions. e) [observed air gaps of approximately I" at bottom of doors to the ante room and from the ante room ro ISO 5 room. u nus IS A REPEATED OBSERVATION."""*.... OBSERVATION 2 Clothing of personnel engaged in the manufact\lring, processing, and packing ofdrug products is not appropriate for the duties they pcrfonn. employees were observed to wear non-sterile lab coats {not full gownlbmmy suit), masks, head covers and booties while producing sterile drug products. Clothing used does not cover neck or forehead of employee during aseptic operations. In addition, an employee was observed not wearing a beard co\ er during the production ofsterile drug products on Sepaember 15, 20 l 5., SEE REVERSE OF THIS PAGE aiplotee(s i SlGNI\1\JRE Claire M. Minden, Investigat or Cta~_;nt~~ O..TEISS~() form RM 4» {01/U) ~JS EllfTIOtOBSOLETE INSPECTTONAL OBSI:UWATJOI\S?AG!l I 014PACES

2 DEPARTMENTOfHEALTH,\l\0 HUMAN SEKVI CES FOOD AND DRUG AOMlNISTRAT!ON OISTfllCT o\oores;; 11>10 P><QNI; >I",JMI!l":" IJA<~R>i w ~SPEC 1""~ 4 04 BNA Dr., Bldg. 200, Ste ~9/l.S/ * ffinumcer Nashville, TN (61S~ Fax: (615) Industry l nformation : NAME Aiiiif~(If ltloj\ii50al"to v:ih&l id.?ollr IS$Vf.U TO; Dr. Rickey L. Chance, President/Owner AR,.W.VE Coastal Meds, LLC. ClrY, &T TE. Z!" t!oo.gouutry ST~f:T ADORUS 1759 Hedical Park Dr. Suite c 1YiE 1:Sf~!IU8,_NTINSPect~O Bi.loxi, MS : Outsourcing Facil~~l OBSERVATION 3 Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, lind fouowcd. Speclfically, a) Media ftljs do not simulate actual production quantities. Currently, your media fills and written procedure, only requires (b) (4) J. b) Jalso observed personnel engaged in op rations in the aseptic processing area on September 15, 2015 reach over tilled pre-stoppered vials to fill other vials behind the filled pre-stoppered vials. The sleeve ofthe non-sterile gown would touch the top of filled pre-stoppered vials during this process. c) Filled pre-stoppered vials are not sealed in a classified area immediately after fillinp.j(o} (4n batches of filled prestoppered vials remained in plastic totes unsea led and unlabeled for up to KID {!) nan area not moni1ored for temperature or humidity. OB SERVATION 4 Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic. conditions. a) You use non-sterile wipes to clean the lso 5 equipment, laminar flow hood and room [(ll) (4) I I b) You have nor performed disinfectant effectiveness testing. c) Your procedure, C I, does oor include contact times and a schedule ofclean ing. OBSERVATION 5 Dntg products do not bear an expiration date detenn ined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. Spec i fical!~-j9u asslrm a one_year "Discard by" date on all of your products. Titis date was determined after aualyzin~ for sterility on (b) (4) ~~ the ~Discard by" date and Jacked potency and stability data. You have no written stability program for determining the beyond-use-date of one year you assign. ** THIS lsa REPEATED OBSERVATION**~<. ( e u PI.OrEii(S) Sl<.l!t TiJl!l:, SEE REVERSE Claire M. Minden, Investigator ~ OF THISPAGE OA"Te"lSUEO form lda Ul (~ PlU;w.lti~Jil»lIOl<Q5!01.En lnspectional OI!SfmVA110lIS J>AO!;; 2 OF 4 PAGES ;.)< :.,. }.:.::=: :.,..

3 -----,.~ l)lshiicyi>oori:ss All:)~ NUI/ISI:K DEPARTMENT OF HEALTH ANn HlllJAI\ Sf.RVCCF,S FOOl) AND DRUG AOMll-llSTR:ATIO~~ lla ltlsj Cf"""""CtlOH 404 BNT\ Dr., Bldg. 200, Ste /15/ " fanuj.ii!er Nashville, TN (615} 366 ~ 7801 Fax: (615) B0755 Industry Information : ~~.fda.gov/oc/industry NAIAE ANt> litl OF tt<ciwiwj. TQM-!d.l ~E~T OSW!ill TO! Dr. Rickey L. Chance, President/Owner III<MH.t.~ Coastal J.leds, LLC. CIJY, ~JY.<ll0,2.1P~"""I<T st~er -ss 1759 Nedical Park Dr., Suite C ryoo "-SJ~... N>P"oiGTUD Biloxi, MS Outsour cing Facility OBSERVATiON 6 There is a failure lo thoroughly review the failure ofa batch or any of its compofl(nts to meet any of its specifications whether or nor the batch has been already distributed. a) You did not conduct an investigation into lot LE/Q$1)81 Sof Lipo-Dcn Extreme when the potency results indicated two ingredients did not meet :your potency specification of-~6) (4)%. 1 This lot was released and distributed by the fimt b) Your invesrigatlon did not extend 10 other baiches of the same drug products for the sterility test f~ilures of lot LP/ for Lipo-Plex and lot LE/ for Lipo-Den Extreme. c) You did not follow your procedure, II 14-06, Out-of Specification-investigations that states, "If any ofthe initial test values fall outside the pre-established specifications, a Laboratory Investigation must be initiated and documentedn. ***THIS IS A REPEATEDOBSERVATION. ~H OBSERVATfON 7 Tnere is a lack of written procedures describing in sufficient deta il the receipt. identification, storage, and examination of labeling and packaging materials. you do not have a \Witten procedure that explains the receipt, identification, storage and examination of finished product labels prior to use nor do you docume nt the cx!l.mination of labels against a label proofto ve-rify the accuracy ofthe label OBSERVATION 8 Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious ami uncxpevted adverse drog experiences which arc required to be reported to FDA. your complaint or recall procedures do not include directions for defining an adverse event or serious adverse event or what steps you will take ifa romplaint involves an adverse event - ~ : - EMP~Ovel;(SI SIGNATURf OI>TEEUOetl SEE REVERSE Claire M. Minden, Investigator ~ OF~THIS. PAGE form FDA 43) (C!IIll)!1\ll\101A!lll1Q)I ~.Elf. INSP CTIONA L OBSERVATIONS PAGEl Vf HAGES

4 ,~ !1CT -OOI(ESS ANCFHOIE NV>.!Cel< m :PARTMENT OF HEALTH Ar..D HUMAN SERVICES FOOD AND DR.lXI ADMI~ISTRA110!1 0A~OI!NS!!:C1!00 0.9/23/2015* 404 BNA Dr,, ~ Bldg. 200, Ste /15/2015 Nashville. TN M2597 f EIIJUMdl!l {615) Fax: (615} Industry Information; WIIW. fda. govjoe/industry N..<E A")mu;Of inlli/()uai.tq...tqu A POI<f 0:SS\Je0 TO : FIRMtiA1oil;: Dr, Rickey._L. Chance,?;resident/Owner STR-"1.ooRess. coastal r-teds, LLC Medical Park Dr., suite C G! TY. STATE. f1f C""".CQIJ>fTRY TYP~ F.ST!\Uli~I><Sf>E:TW "- Biloxi, MS Outsourcing Facility OBSERVATION 9 The labels ofs.)ide ofyour outsourcing facililys drug products do not include information required by section 503B(a)(IO)(A} and {B). The following information is not foond 011 some ofyour drug product labels. as required. by section 503B(aX I O)(A): 1. The statement, "This is a compounded drug." 2. The full address of the outsourcing facility. 3. The dosage fonn of the product. 4. The statement, Not for resale," and if the drog is dispensed or distributed other than pursuan! to a pre-scription for rut individual patient, the statement, Office Use Only." The following information is not found on or in the containers for some drug products you produce, as described in section 503B(a)( 10)(8): I. Information to facilitate adverse event reporting: and 1~800-FOA - 108& <hnn:// FDA-1 088>: Examples ofdrug product labels that do not contain this infonnation include: Lipo-Dcn Extreme JOmL, Pyridoxine l 00 mglml, Upo-P iex 30mL, Upo ml, Lipo-Den Pius 30 ml, Cyanocobalamin 1000 mcglml in 30 ml, Methylcobalamin 30 ml, Lipo~Den 30 ml, Hydroxocobalamin 30 ml, Lipo- Den Max 30 tnl, Rooex 30 ml, Adeno-Picx 30 ml, Methyi P!ex 30 ml OBSERVATION 10 Your outsourcing facility.has not submitted product reports to FDA as required by section 503B(b){2){A)... " DAn:s OF INSPECTION: 09/1 5/20! 5(Tue), 09116/2015(\Ved), 09/l7/20l5(Thu), 09123/20 IS(Wed).SEE REVERSE -Qf_THIS PAGE sjgaanjr Claire M. Minden, Investigator (!.iaw..:nr.~ Wlll;;ISSI..EII FORM FI>A 4&.3 jll!llo!i rn\10<js mmo11 OO$I01.P.TP. lnsp F.ClJONAL OBSERVATIONS PA.(ill4 Of ~ MOI>S

5 The observations of objectionable conditions and practices listed on the front of this form are reported: 1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: "Upon completion of any such Inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the Inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food. drug, device, or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance. or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."