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STATE OF Wt\SHI'NOTON

Department of HealthBoard of Phannacy

P.O. Box 47863 . Olympicl, Washington 98504.7863

Telephone: (360) 236-4825. Facsimile: (360) 586-4359

MEMORANDUM

Date: October t 4, 2005

To: Grace Cheung, Chief Investigator

cc: Stan Jeppesen, Phannacist It)vestig~tor

From: Kelly McLean, Phannacist Investigator

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R'£: New Wholesaler/Manufacturer Inspection fQrBio Med Comm Inc, done.September 29,2005

On Sept!~mber29,2005, Phannacist Investiga.tor Kelly McLean, accompanied by UW externRobert Kahtls,conducteda newfirm inspectiona.tBio MedCommlocatedat 1551OWoodinvilieRedlt10nd Road NE, Building # E, located itl Woodinville WA 98072, The inspection was basedon Bio ~.led Comm's application for Wholesaler/Manufacturer license # FX58412 with theDepartment of Health, Washington State Board of Pharmacy.

l:pOt inrrcductionto the facility~InvestigatorMcLeanquestionedthe CEOof Bio Med Corom.~',- Ed;~.ra Brewitt whether theJ'ehad been any manufacturing prior to this inspection. Dr.:>~r,:\'i~::'i~':\iedthat there was Cinysuchaction.

The inspc;ction process included but was not limited to: a tour of the manufacturing facility,includinga tabtet room,a liquid manufacturing room containing a refrigerator with Evel' clearar:d IJbfa;y chemical components from Dolisos America of Las Vega.s;an overview of theC0l'pOratf' structure; a review of the drug manufacturing process; a,review of the process flowdi.3gram; a review of instructions on designation of lot numbers for manufactured product; and a

r.evie 0:'11dilution fi-om the library ~aterial record.

-r>.;) i;1Sp',dionperfolmedon September29,2005 disclosedmanyWashingtonState GoodMf-',rmfac"uringPractice(GMP)deficiencies: . (;0008'5

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1. WAC 246-895-030(1) It appearedthat there wereno ptovisionsfor documentationoftraining which would ensure that the drug has the safety, identity, strength, quantity,andpuritythat it purportstopossess.' . "

2." WAC 246.895-040 (1) (b) It was observed that there were no provisions for receipt,storage, and withholding from use of components pending sampling, identification, andtesting prior to retease bythe qualitycontrol unit. Therewas no logor computerfortracking these components:

3. WAC 246-895-040(1) (c) It appearedthere was no provisionfor holdingof rejected"componentsprior to dispositionto precludethe possibilityof their use in manufacturingor packagingproceduresfor whichtheyare ul"lsuitable. "

4, WAC 246-895-040(2) 1twas noted that the floor in the tablet room was not completelysealed around the entire perimeter of the room. " "

5. WAC 246-895-040 (3) It was observed that there were 110staffIockers or a sink for hand

washing in the facility. Accessible restrooms were available in the adjacent '(ElegantGourmett> warehouse.

6. . WAC 246-895&040 (4) It was observed that there was no provisions for adequate potablewatersupply. " "

7. WAC 246-895-060 (1) There was no calibration identification sticker on a scale which"fyasused in-the liquid production room. There also were no policies and procedures in;: Ice for maintenance and regular calibration of equipment, other than their vertioal andlcrizontal flow hoods which had stickers which documented certification. .

8. "VI'AC 246-895-060 (9) It was observed there W!l.Sa lack of policies and procedures fordocumentation of batch failure.

9. WAC 246-895-060 (I 0) {twas ooted there was no quarantine area for returned goods-10. WAC 246-895-070 (2) There is no provision for sample testing, documentation, and

i"eiease to the quality control personnel,or reservationof samplesof all activeingredients. .

t I. VIAC246~895-100 (8) There was no provisions (such as a log book or a computer withroftware) for maintaining complete laboratory data related to each batch or to which they~.pply. "

n. ''AlAC246.895-110 There was no observed provisions for testing the stability of finishedf:roduct.

1.3. 'VAC 246-895-130 (d) Labels which were to be used upon licensure and for product to. te manufactured were not limitedaccess,but on a shelf in the lobby ofthe building.

14. WAC 246-895-150 (1) There is no system in place for which the distribution of each lotaf dmg can be readily determinedto facilitateits recall if necessary. .

15, '\' AC246-895~160There is no policy and procedure for maintaining a complaint file.

Based on the above observations, Investigator McLean verbalized to Dr. Brewjtt, wi,th JeremyAdler, technical staff, and Susan, the aCCOlll1tant present that the finn failed inspection and the:'::::;~;\"I~d~' 'idencies would haveto be.rectifiedanda re-inspectiondonepriorto licensure.

Af1:erward!;:, Investigator McLean and Robert Kahns made a visit to the corporate office of BioM~d COIT..IDInc. located at 6 Nickerson Street, Suite 210, loc~tedin Seattle98109. First,-itf. met ",ith Marie Brown, Office Assistant, and relayed the ~bove information regardinginspection failure and the deficienoies noted. Last, Investiga.tor McLean viewed the office spaceinducing an area for Ped Ex shipping which contained several cases of tablets with the names"Enduran:;e Plus" Natural Menopause Relief' and "Athletic Edge" and a small areawhich

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. .s;.QTI':s,in!dabout a dozen amber dropper via.ls,which Ms. Brown stated"that she1eftthemtherebeca.useDr. Brewitt could identify them and was going to take care ofthem".

~:hc,,,tly after the inspection and corpQrate site visit, Investigator McLean received a phone callfrom M::. Jeremy Adler, technical staff at the facility who sta.ted that Dr. Brewitt had removedsome ccmponents which she did not want me to view and placed them in her ca/' until I hadexited a.fter the inspeciion took place. She then replaced the concentrated ptodu.cts andproduct'on materials back in the liquid manufacturing room.

Per Mr. Adl~r>srequest, Investigator McLeanmade a Woodinville site visit on the morning ofS~:pt:~ro.ber30, 2005. She left a copy of "Chapter 246-895WAC GoodManufacturing Practice~';;r j: bi: hl~dPhanne.ceuticals" for Dr. Brewitt to review. During Investigator McLean's visit,itwas obs'mred that he was in the process of manufacturing a dilution of a product for release. Iwas una'~le to see any identification ofthe concentrate from which this liquid dilution wasd~ived: which if this was a.licensed manufacturer. is a violation of wAc 246-895-060 (2}.A.lso, r was not able to identify the' unlabeled amber dropper vials which had been'produced byJeremy prior to my visit. In the refrigerator, I observed several amber bottles which were absentthe day bE>foreduring tny inspection.. Thes.e productsincluded insulin,fibrinogen,and growthhormone liquids. I took photos 'Ofthese items with my palm pilot for future use.

On Sept(}mber 30. 2005~based on the foregoing, Investigator Mclean Kelly McLean phonedLise. Salmi and filed a complaint for investigation on this unlicensed Wholesaler/Manufacturerf:',n,

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3ASI# 2005-10-0005 CS-I0281

Att#_I_Page ,3 of-

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STATE011WASHINGTON

Department of HealthBoard of Pharmacy

p,o, Bo'X'4786J. Olympia,Washington98504~i863Telephone: (360) 236.4825 . Hu:.~'imile: (360) 586~4359

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MEMORANDUM

Date: De~ember 16, 2005

To: Grace Cheung, Chief Investigator

FtOm~

Stan Jeppesen, InvestigatorDarlene Tiffany, Phannacy Firms Licensing

Kelly McLean, Investigator \('\'1\""-

cc:

Re: New Export Wholesaler/Manufacturer Applioant re-inspections for Bio MedComm Ioc. (FX 58412)

On November 28, 2005, Pharmacist Investigator Kell:YMcLean conducted a re:.iJ1spectionofapplicant Bio Med Comm. The inspection took place at the manufacturing suite located at 1550

. Woodinville Redmond Road #E in Woodinville98072. Dr. BarbaraBrewitt accompaniedmeduring the inspection process. Also present was a consultant named Linda Mickelson.

The inspection process included but was not limited to: a tour ofthe manufacturing facility,including a tablet room, a liquid manufacturing room containing a refrigerator with Ever clearand library chemical components from DoUsos America of Las Vegas; an overview of thecorporate structure; a review ofihe drug manufacturing process; a review of the process flowdiagram; a review ofiostructions on designation of lot numbers for manufactured product; and areview of a dilution from the library material record.

The illSpectionperfonned on November 28,2005 disclosed many additionaldeficiencies (pleasesee Memo from September 28,2005 lospeotion) .

1. WAC 246-895-030 (1) It appeared that there were no provisions for documentationoftraining which would enSllrethat the drug has the safety, identity,strengtb, quantity, andpurity that it purports to possess.

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2. WAC 246-895.040 (1) (b) It was observed that there Were provisions for receipt, storage,andwithholding from useof components pendingsampling, identification, and testingprior to release by the qualitycontrolunit. However,there was no provisions fordocumentationof quantity, natnaof supplier, suppliers lot number, or disposition ofrejected items (if applicable) on the log book presented.

3, . WAC 246-895-040(2) Theprovisionsfor temperatureand humidity controlwerenotmaintained as the adjacent suite (ElegantGounnet) had shut off the heat during theprevious week for Thanksgivingholiday,and the temperature was e&tremely cold, Therewas no thennometer or humiditycontrol in any partof the suite. .

4. WAC 246-895-060 (I) There was no calibration identification sticker on a scale whichwas used in the liquid productionroom, There was a policy at'Idproeedure in place formaintenance a.nd regular calibration of equipment; l10wever the fom presented forcalibration of equipment and documentation of such for equipment on site was notcompleted. including certificates of calibration from a company who perfonns suchs~rvices. .

5. WAC 246-895-060 (9) It was observedtherewas a lack of policies and procedures fordocumentation of batch failure.

6. WAC 246-895-140 There was no provisions'(such as a log book or a computer with. software) for maintaining completelaboratorydata related to each batch or to which they

apply. There was one example of a Master Batl;h Record for the product CSE 1 only.(See Atta.chment 1-1). When asked for an example of other product batch records, Dr.Brewitt commented that the rest ofllie Batch Records were on her computer at thecorporate office in Seattle. .

7, WAC 246-895-150 (1) There is no system in place for which the distribution of each lotof drug can be readily detenninedto facilitate its recall if necessaiy, There was nopolicy and procedure that was in the operations manual presented tQ.me which outlinedthis process. Dr, Brewitt was told that on the invoices sent to cl.1stomers, a lot numberneeded to be attached to each line item of products sent

Based on the above observations, Investigator McLean had a discussionwith Dr. Brewittregarding the above deficiencies which needed to be rectjfied prior to re-inspection andlicensure. In reference to the September \ 12, 2005 deficiencies, Bio Med Corom did meetcompliance with the quarantine area and security of product label rolls i~ a locked cabinet, Atthe requested of Or. Brewitt, she thought she c()uld be within compliance later in the week, a.ndare-inspection was scheduled for December I, 2005

December 13.2905 Re-lnspectiot'\

Due to unforeseen circumstances, Investigator McLean had to re-schedule the subsequentinspection OJ'!December 13,2005. The first portion of the visirwasma.deto the corporate officeof Bio Med Camm Inc. located at 6 NickersonStreet,Suite 210, located in Seattle 98109. MarieBrown, Office Assistant was present during the jospection.

First, an observatioo of the outgoing customer shipping invoices was done, The invoices whichwere viewed were from the first of Deoember to this date. It was noted that some invoicescontained 00 IQtnumbers for tracking, while others hadsomeitemswitha lotnumberandotherswere not listed for tracking. Next, Investigator McLean vjewed the policy and prQcedureforshipment of customer product, and it did not includeprovisionsfor assigning lot numbers fortrackingof product,shouldtherebea reasonto recalltheproduct.Copiesof two invoicesfor

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Costco Wholesale and Dr. Gregory Peechatt (see Atta.chment2-3 and 3~6, respectively). Dr.Brewitt was told that on the previous inspectionon November 28, 2005 inspection it had beenspecified to her that lot numbers needed to be assigned to each line item that was shipped to thecustomer, and they were stilt not in compliance.

Next, I observed two cases of liquid productpackaged in amberdropper vials (CSE 8, CSE 14,and CSE 20) whioh were on the floor near the entry to the shipping area. Dr. Brewitt stated thatthese had come from a company oalled ASI located in Las Vegas. I askedfor a copy oftheinvoice, which she prpvided (see Attachment 4-7). I asked permission to uSe the phone to calland verify authenticity of this company, since she was using. this as a new supplier of product,and the product label 2lliY denoted that it was distributed by Bio Med Comm, without referenceto this company

The owner of the company, named Ja.ckHackreturned my call. He stated that ASl hadmanufactured this product for Bio Med Corom, however, Dr. Brewitt had sent intermediatepreparations and provided Certifica.tion of Dilution Preparation for each product jntended to beused by ASI to ntanufacture; CSB 8, CSE 14, and CSE 20. I asked Mr. Hack to fax me a copy of.these right away, and J was able to get them from the fax without Dr. Brewitt's observation ofwhat was inooming. Please refer to Attaohments 5-8, SM9,and 5-10 for documentation ofCertificate of Dilution Preparation provided to ASI from Bio Med Comm on November 22,2005.

J asked Dr. Brewitt if she had any future intent on having any other company manufactureproduct for Bio Med Comm. She provided me with a letter of intent for a company called Natura.in SOl,1thAfrica (see Attachm.ent 6-11, 12, 13). In addition, she also provided me with copies ofCertificates of Analysis for product obtained from R&D systems (Attachment 7). They werelisted on Bio Med Comm's poHcyand procedureon "Approved Suppliers (see Attachment 8).She also mentioned that she had an Arizona physician Dr. Ga.ry Gordon, write prescriptions forher at Ballard Plaza. Pharmacy for Insulin and Norditropjn.

laSt portion of the inspection was spent reviewing policies and procedlues for Master Batchrecords. On the November 28, 2005 inspection, Dr. Brewitt had stated that she had on hercomputer files records for Master Batch formulations for her 23 products. When asked aboutthese, she admitted that she did not have them, and agait1showed me the only one shedid havedone for CSE I production. r told her that during the course of a manufacturer jnspection; onewould see an offering of two or three sampJe batch records (if the company produced severalproducts). I told her it was una.cceptableto not have these and referred to the November 28,2005 comments that she needed to have them ready for revj~w. She was not forthcoming withme on that date, as she told them she had them on her computer but indeed does not.

I told her that I would make arrangements to meet her in WoodinvilIe later that afternoon to goover the physical plant there. I then met Dr. Brewitt and her assistant SeHneover at theWoodinville site. I noticed addition oftemperature mon.jtorsInthe lobby and liquid room. I alsonoticed that a temperature and humidity monitor had been added to the tablet manufacturingroom. Uponinquiry of whichproductsshe intendedto manufacturewith thE!:four tablet-pressdies she had ava-Hable)she responded accordingly: the "H" wa.s fOf "Natural Menopause Relief',.IHR-IGF1" wasfor "EndurancePlusl\and"HRHGHnwasforNaturallyHOH"andltAthletic .

Edgo~l. I a5kcd ifshe realized thal there was a law which states that each product should have aunique identifier. She stated that she wasjust mimicking what the manufacturer Dolosis.had

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done 8;9far as imprinting the products-"Natural1YHR~HGH"and"AthleticEdge'>,andstatedsheguessed what Dolosis had done was itlega!.Furthermore, I requested to view the tablet imprint die which was currently on the tabJet pressmachine;aftermanymanipulationsofthe machine(with referenceto the manual)shewasunableto pull the imprintdie off, but I was able to view the die as CSB20. Dr. Brewitt said this CSE20wasto producea tabletwhichwas to be exported to a location il1South Africa, not here. Iexpressed concern over her inability to operate the tablet press in respect to future aspirations tomanufa.ctureproductupon licensure, I finishedmy inspectionwitha reviewofthe equipmentcalibration documentation, which was in compliance.

At our exit interview 1provided reference to the fonowing deficiencies which would have to beaddressed prior to schedtl1ing another inspection with her.

. 1. WAC 246-895-140 There was no provisions (such as a log book or a computer withsoftware) for"maintaining complete laboratory data related to each batch or to which theyapply. There was one example of a Master Batch Record for the product CSE 1 only.

. (See Attachment) -1). When asked for an ex.ample of other product batch records, ProBrewitt commented that the rest of the Batch Records were on her computer at thecorporate office in Seattle, which they were not upon inspection today.

2. WAC 246-885-030(4) No non-imprintedsotid dosage form that is il:ltendedfor OTC salemay be sold or distributed under the state of Washington. Thjs is in reference to the"HR HGH" tablet imprint die which was intended for Naturally HGH" a"d "AthleticEdge". She could not use the imprint for one, and leave the other blank. Each had tohave its own identifier. -

3. WAC 246-895w150 Finished goods wa.rehouse control and distribution procedure did nothave provisions for application of the lot number to each and every product which wasdistributed. Observation of the currerit standard operating procedure and rec.ent outgoingshipment invoices from the month of December did not reflect that Bio Med Comm wasin compliance with this as a mechanism to aid with product recall.

Before I left the Woodinville site, 1 told Dr. Brewitt that in the interest of time, I would like towait to schedule a reftinspection until she feels that Bio Med Comm can meet the all ofrequirements of compliance to obtain a manufacture's and export wholesaler license. Dr. Brewittphoned on December) 4, 2005 to schedulean inspection and I gra.ntedan inspectiontime ofDecember 21, 2005 afternoon.

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