Sample Memo to Ceo of Wholesale Supply Company - PDF by wqc15865

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                                                STATE OF Wt\SHI'NOTON                                                    ~
                                                                                                                         .....
                                              Department of Health
                                               Board of Phannacy
                                                                                                         ~I    II ~I II tl
                             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

    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 extern
    Robert Kahtls,conducteda newfirm inspectiona.tBio MedCommlocatedat 1551       OWoodinvilie
    Redlt10nd Road NE, Building # E, located itl Woodinville WA 98072, The inspection was based
    on Bio ~.led Comm's application for Wholesaler/Manufacturer license # FX58412 with the
    Department of Health, Washington State Board of Pharmacy.

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

    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' clear
    ar:d IJbfa;y chemical components from Dol isos America of Las Vega.s;an overview of the
    C0l'pOratf' structure; a review of the drug manufacturing process; a,review of the process flow
    di.3gram; a review of instructions on designation of lot numbers for manufactured product; and a
    r.evie      0:'11 dilution fi-om the library ~aterial   record.

                                           2
    -r>.;) i;1Sp',dionperfolmed on September 9,2005 disclosedmany WashingtonState Good
    Mf-',rmfac"uring  Practice(GMP)deficiencies:                                        .
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                                                                                            ASI# 2005-10-0005 C8-10281
                                                                                            Att#.,..'- Page
                                                                                                          -L   of-
                                                                                    KI:.LL   Y   Ml.'LI::AN
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                    1.    WAC              (1)
                                 246-895-030 It appeared there were no ptovisionsfor documentation
                                                       that                                       of
                          training which would ensure that the drug has the safety, identity, strength, quantity, and
                                              to
                          puritythatit purports possess.'                                                         .                             "



                    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, and
                        testing prior to retease bythe qualitycontrol unit. There was no log or computerfor
                        tracking these components:
                    3. WAC 246-895-040(1) (c) It appeared      there was no provisionfor holdingof rejected"
                        componentsprior to dispositionto precludethe possibilityof their use in manufacturing
                                  proceduresor whichtheyare ul"lsuitable.
                       or packaging         f                                                                              "


                    4, WAC 246-895-040(2) 1twas noted that the floor in the tablet room was not completely
                          sealed 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 '(Elegant
                          Gourmett> warehouse.
                    6. . WAC 246-895&040 (4) It was observed that there was no provisions for adequate potable
                          watersupply.                                                           "                                          "




                    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 and
                           lcrizontal flow hoods which had stickers which documented certification.               .

                    8.    "VI' 246-895-060 (9) It was observed there W!l.S lack
                            AC                                           a                               of policies and procedures for
                          documentation 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 active
                          ingredients.                                                                                .
                     t I. VIAC 246~895-100 (8) There was no provisions (such as a log book or a computer with
                          roftware) for maintaining complete laboratory data related to each batch or to which they
                          ~.pply.                                                                                                  "




                     n.   ''AlAC 246.895-110           There was no observed provisions for testing the stability of finished
                          f:roduct.
                      3
                     1. . 'V AC 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 lot
                          af dmg can be readily determinedto facilitateits recall if necessary.        .
                                      160
                     15, '\' AC246-895~ There is no policy and procedure for maintaining a complaint file.


                Based   on the above observations, Investigator McLean verbalized to Dr. Brewjtt, wi,th Jeremy
                Adler, technical staff, and Susan, the aCCOlll1tant present that the finn failed inspection and the
                        d~' 'idencies would have to be.rectified anda re-inspection
                :'::::;~;\"I~                                                         donepriorto licensure.

                Af1:erward!;:, Investigator McLean and Robert              Kahns made a visit to the corporate office of Bio
                M~d COIT..ID located at 6 Nickerson Street, Suite 210, loc~tedin Seattle 98109. First,
                                Inc.
                -itf. met ",ith Marie Brown, Office Assistant, and relayed the ~bove information regarding
                inspection failure and the deficienoies noted. Last, Investiga.tor McLean viewed the office space
                inducing 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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                              .                                                                .
                about a dozen amber dropper via.ls,which Ms. Brown stated "that she1eftthem there
    s;.QTI':s,in!d
    beca.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 call
    from M::. Jeremy Adler, technical staff at the facility who sta.ted that Dr. Brewitt had removed
    some ccmponents which she did not want me to view and placed them in her ca/' until I had
    exited a.fter the   inspeciion   took place. She then replaced the concentrated ptodu.cts and
    product'on   materials back in the liquid manufacturing        room.

    Per Mr. Adl~r>srequest, Investigator McLean made a Woodinville site visit on the morning of
    S~:pt:~ro.ber 30, 2005. Sheleft a copy of "Chapter 246-895WAC GoodManufacturing Practice
    ~';;rj: bi: hl~d Phanne.ceuticals" for Dr. Brewitt to review. During Investigator McLean's visit,it
    was obs'mred that he was in the process of manufacturing a dilution of a product for release. I
    was una'~le to see any identification ofthe concentrate from which this liquid dilution was
    d~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 by
    Jeremy prior to my visit. In the refrigerator, I observed several amber bottles which were absent
    the day bE>foreduring tny inspection.. Thes.e productsincluded insulin,fibrinogen,and growth
    hormone 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 phoned
    Lise. Salmi and filed a complaint for investigation on this unlicensed Wholesaler/Manufacturer
    f:',n,




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                                                                                                    ASI# 2005-10-0005   CS-I0281
                                                                                                    Att#_I_Page ,3 of-
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                                                 011
                                             STATE WASHINGTON
                                           Department of Health
                                            Board of Pharmacy
                             p,o, Bo'X'4786J. Olympia,Washington      98504~i863
                           Telephone: (360) 236.4825 . Hu:.~'imile: (360) 586~4359


                                                                             ( ',;..'

                                               MEMORANDUM


      Date:              De~ember 16, 2005

      To:                Grace Cheung, Chief Investigator

      cc:                Stan Jeppesen, Investigator
                         Darlene Tiffany, Phannacy Firms Licensing

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

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



          On November 28, 2005, Pharmacist Investigator Kell:YMcLean conducted a re:.iJ1spectionof
          applicant Bio Med Comm. The inspection took place at the manufacturing suite located at 1550
      .   Woodinville Redmond Road #E in Woodinville 98072. Dr. BarbaraBrewitt accompaniedme
          during 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 clear
          and library chemical components from DoUsos America of Las Vegas; an overview of the
          corporate structure; a review ofihe drug manufacturing process; a review of the process flow
          diagram; a review ofiostructions on designation of lot numbers for manufactured product; and a
          review of a dilution from the library material record.

          The illSpectionperfonned on November 28,2005 disclosed many additional deficiencies (please
          see Memo from September 28,2005 lospeotion)                                                   .




              1. WAC 246-895-030 (1) It appeared that there were no provisions for documentationof
                 training which would enSllrethat the drug has the safety, identity,strengtb, quantity, and
                 purity 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,
           and withholding from useof components pending        sampling, identification, and testing
           prior to release by the quality controlunit. However,there was no provisions for
            documentation of quantity, natnaof supplier, suppliers lot number, or disposition of
            rejected items (if applicable) on the log book presented.
       3, . WAC 246-895-040(2) Theprovisions temperature and humidity controlwerenot
                                                    for
            maintained as the adjacent suite (ElegantGounnet) had shut off the heat during the
            previous week for Thanksgivingholiday, and the temperature was e&tremely cold, There
            was no thennometer or humiditycontrol in any part of the suite.           .

       4. WAC 246-895-060 (I) There was no calibration identification sticker on a scale which
            was used in the liquid productionroom, There was a policy at'Idproeedure in place for
            maintenance a.nd regular calibration of equipment; l10wever the fom presented for
            calibration of equipment and documentation of such for equipment on site was not
            completed. including certificates of calibration from a company who perfonns such
           s~rvices.                                .

        5. WAC 246-895-060 (9) It was observedtherewas a lack of policies and procedures for
                 documentation 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 the
                 corporate office in Seattle.                .

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


    Based on the above observations, Investigator McLean had a discussion with Dr. Brewitt
    regarding the above deficiencies which needed to be rectjfied prior to re-inspection and
    licensure. In reference to the September 12, 2005 deficiencies, Bio Med Corom did meet
                                                   \



    compliance with the quarantine area and security of product label rolls i~ a locked cabinet, At
    the requested of Or. Brewitt, she thought she c()uld be within compliance later in the week, a.nda
    re-inspection was scheduled for December I, 2005

                                         December 13.2905 Re-lnspectiot'\

    Due to unforeseen circumstances, Investigator McLean had to re-schedule the subsequent
                  D                                                         to
    inspection OJ'! ecember 13,2005. The first portion of the visirwasma.de the corporate office
    of Bio Med Camm Inc. located at 6 NickersonStreet,Suite 210, located in Seattle 98109. Marie
    Brown, Office Assistant was present during the jospection.

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

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f   , . .


            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 been
            specified to her that lot numbers needed to be assigned to each line item that was shipped to the
            customer, 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 that
            these had come from a company oalled ASI located in Las Vegas. I askedfor a copy ofthe
            invoice, which she prpvided (see Attachment 4-7). I asked permission to uSe the phone to call
            and 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 reference
            to this company

             The owner of the company, named Ja.ckHack returned my call. He stated that ASl had
             manufactured this product for Bio Med Corom, however, Dr. Brewitt had sent intermediate
             preparations and provided Certifica.tion of Dilution Preparation for each product jntended to be
             used 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 of
                                                                         a
             what was inooming. Please refer to Attaohments 5-8, SM9, nd 5-10 for documentation of
             Certificate 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 manufacture
            product for Bio Med Comm. She provided me with a letter of intent for a company called Natura.
            in SOl,1th Africa (see Attachm.ent 6-11, 12, 13). In addition, she also provided me with copies of
            Certificates of Analysis for product obtained from R&D systems (Attachment 7). They were
            listed 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 for
            her at Ballard Plaza. Pharmacy for Insulin and Norditropjn.

            laSt portion of the inspection was spent reviewing policies and procedlues for Master Batch
            records. On the November 28, 2005 inspection, Dr. Brewitt had stated that she had on her
            computer files records for Master Batch formulations for her 23 products. When asked about
            these, she admitted that she did not have them, and agait1showed me the only one she did have
            done for CSE I production. r told her that during the course of a manufacturer jnspection; one
            would see an offering of two or three sampJe batch records (if the company produced several
            products). 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 with
             me 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 go
             over the physical plant there. I then met Dr. Brewitt and her assistant SeHneover at the
             Woodinville site. I noticed addition oftemperature mon.jtorsInthe lobby and liquid room. I also
             noticed that a temperature and humidity monitor had been added to the tablet manufacturing
             room. Uponinquiry of which products she intendedto manufacturewith thE!:our tablet-press
                                                                                            f
                                    s
             dies she had ava-Hable) he responded accordingly: the "H" wa.s fOf "Natural Menopause Relief',
             .IHR-IGF1" wasfor "Endurance     Plusl\and"HRHGHnwasforNaturallyHOH"andltAthletic .
             Edgo~l. I a5kcd ifshe realized thal there was a law which states that each product should have a
             unique identifier. She stated that she was just mimicking what the manufacturer Dolosis. had




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       done 8;9far as imprinting the products-"Natural1Y   HR~HGH"                          and
                                                                       and"AthleticEdge'>, statedshe
       guessed what Dolosis had done was itlega!.
       Furthermore, I requested to view the tablet imprint die which was currently on the tabJet press
                                             o
       machine;aftermanymanipulations fthe machine           (with referenceto the manual)she wasunable
       to pull the imprint die off, but I was able to view the die as CSB20. Dr. Brewitt said this CSE20
       wasto producea tabletwhichwas to be exported to a location il1South Africa, not here. I
       expressed concern over her inability to operate the tablet press in respect to future aspirations to
                     p
       manufa.cture roductupon licensure, I finishedmy inspection        witha reviewofthe equipment
       calibration documentation, which was in compliance.

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

          . 1. WAC 246-895-140 There was no provisions (such as a log book or a computer with
                software) for"maintaining complete laboratory data related to each batch or to which they
                apply. 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, Pro
                Brewitt commented that the rest of the Batch Records were on her computer at the
                corporate office in Seattle, which they were not upon inspection today.

                                                                                          for
           2. WAC 246-885-030(4) No non-imprintedsotid dosage form that is il:ltended OTC sale
              may 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 "Athletic
              Edge". She could not use the imprint for one, and leave the other blank. Each had to
              have its own identifier.                      -

           3.     WAC 246-895w150 Finished goods wa.rehouse control and distribution procedure did not
                  have provisions for application of the lot number to each and every product which was
                  distributed. Observation of the currerit standard operating procedure and rec.ent outgoing
                  shipment invoices from the month of December did not reflect that Bio Med Comm was
                  in 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 to
       wait to schedule a reftinspection until she feels that Bio Med Comm can meet the all of
       requirements of compliance to obtain a manufacture's and export wholesaler license. Dr. Brewitt
       phoned on December) 4, 2005 to schedule an inspection and I gra.ntedan inspection time of
       December 21, 2005 afternoon.




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