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    2015 FDA Inspection

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    Anonymous Pb39klJ
    The FDA conducted an inspection of Pharm D Solutions, an outsourcing facility, and observed 8 issues: 1) Media fill simulations did not adequately simulate production conditions. 2) Environmental and air monitoring was insufficient. 3) Batch sterility testing procedures were inadequate. 4) Equipment used to control aseptic conditions was not properly monitored or qualified. 5) Batch production records were incomplete. 6) Labeling for drug products was deficient and did not meet legal requirements. 7) Cleanroom disinfection procedures and monitoring needed improvement. 8) Drug product labels were missing required statements and use information.

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    2015 FDA Inspection

    Uploaded by

    Anonymous Pb39klJ
    205 views4 pages
    The FDA conducted an inspection of Pharm D Solutions, an outsourcing facility, and observed 8 issues: 1) Media fill simulations did not adequately simulate production conditions. 2) Environmental and air monitoring was insufficient. 3) Batch sterility testing procedures were inadequate. 4) Equipment used to control aseptic conditions was not properly monitored or qualified. 5) Batch production records were incomplete. 6) Labeling for drug products was deficient and did not meet legal requirements. 7) Cleanroom disinfection procedures and monitoring needed improvement. 8) Drug product labels were missing required statements and use information.

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    2015 FDA Inspection

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    The FDA conducted an inspection of Pharm D Solutions, an outsourcing facility, and observed 8 issues: 1) Media fill simulations did not adequately simulate production conditions. 2) Environmental and air monitoring was insufficient. 3) Batch sterility testing procedures were inadequate. 4) Equipment used to control aseptic conditions was not properly monitored or qualified. 5) Batch production records were incomplete. 6) Labeling for drug products was deficient and did not meet legal requirements. 7) Cleanroom disinfection procedures and monitoring needed improvement. 8) Drug product labels were missing required statements and use information.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    205 views4 pages

    2015 FDA Inspection

    Uploaded by

    Anonymous Pb39klJ
    The FDA conducted an inspection of Pharm D Solutions, an outsourcing facility, and observed 8 issues: 1) Media fill simulations did not adequately simulate production conditions. 2) Environmental and air monitoring was insufficient. 3) Batch sterility testing procedures were inadequate. 4) Equipment used to control aseptic conditions was not properly monitored or qualified. 5) Batch production records were incomplete. 6) Labeling for drug products was deficient and did not meet legal requirements. 7) Cleanroom disinfection procedures and monitoring needed improvement. 8) Drug product labels were missing required statements and use information.

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    You are on page 1of 4

    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    FOOD AND DRUG ADMINlSTRATION


    DIS ICT ADOAESS AND PHONE NVIoi!IER OA E(S) OF INSf'f-CTlCN

    Expressway, Su i te 300 05/28/2015 - 06/05/20 15*


    F tt«AeER

    3011043 554

    TO: Luis Ri cardo de Leon, Executive Offi cer and Pharmacis t in Charge
    FIRM NAME ST'fteET ADOAI!SS

    130 4 S Loop W
    Est ISHMENT INSPECTED

    Houston, TX 77054-4010 Outsour cing Facility

    This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional
    observations, and do not represent a fmal Agency detennination regarding your CQmpliance. ff you 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 or
    action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. Ifyou have any
    questions, please contact FDA 81 the phone number and address above.

    DURING AN INSPECnON OF YOUR FIRM I OBSERVED:

    OBSERVATION 1

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

    Specifically,

    A) Your media fill simulations are not performed under the most stressful and challenging conditions. For example,

    l. The media fills dated 4/2/2015 and 4/612015 were conducted with a total ofl vials d~lontrol and!Biest vials). The Ill
    lots produced on 5/2612015 consisted ofsyringes and eye droppers which were not evaiuated in the media fills.

    2. The media fills dated 4/2/2015 and 4/612015 failed to simulate the set-up process using rmJG)J For example, the £
    product "Columbus Quad Opthalmic Compound Opthalmic" (Ketorolac Tromethamine, u"SP"Q.5W;D, t'henylepbrine HCI. USP
    2.5%, Tropicamide, USP 1%, Tetracaine HCI, USP 0.5%), lot # 05261503-JDL required the use o~ • •
    [ I U D . -· The media fills utilizedRDUM. (b) (4 ) in the fin~

    3. The media fills dated 412/2015 and 4/612015 were not performed under conditions which s imulate actual production.

    OBSERVATION 2

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

    Specifically, your finn's procedures for monitoring th- ISO S LAF hood are not suitable to ensure the quality ofair. For
    example,

    A) During periods of production, your finD does not conduct viable air monitoring or surface sampling.

    B) Testing for non-viable particulates is not conducted under dynamic conditions.

    C) Your firm has not conducted surface monitoring ofthe pass through window between th- SO 7 rooms.

    DATE ISSUED

    SEE REVERSE Stephen D. Brown, Investigator


    06/05/2015
    OF THIS PAGE

    FORM FDA 4&3 ( INSPECTIONAL OBSERVATIONS PAGEl OF 4 PAGES


    OBSERVATION 3

    Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.

    SpecificaiJy, s11itability testing for your ~ test used to assess the sterility of finished drug products has not
    been perfonned. In addition, negative c~utilized.

    OBSERVATION.

    Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic

    conditions.

    Specifically,

    ~ssure differentials are not alanned. In addition, the pressure differentials are checked only at (b) (4 )

    B) ln regard to smoke studies, on 6/1120 15, your finn placed a of the . ISO 5 laminar
    flow hood an~·--­
    However, the
    study is incomplete in that:

    I. Your firm failed to establish a protocol describing the acceptance criteria for the study.

    2. 1be smoke study was not performed under dynamic conditions to verify that the operator or activities in the ISO 7
    cleanroom do not affect the unidirectional airflow from the HEPA filters in the ISO 5 hood where drug products are
    roduced.

    OBSERVATION &

    Batch production and control records do not include complete information relating to the production and control of each

    batch.

    Specifically. )Our production records do not include a description of of the production process including
    OBSERVATION 6

    Batch production and control records do not include complete labeling control records, including specimens or copies ofall
    labeling used for each batch ofdrug product produced.

    Specifically. the specimens/copies oflabels for the drug products which comprise the Quad Opthalmic Compound have not
    been retained.

    OBSERVATION 7

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

    Specifically,

    A) SOP #5.002 entitled. '' l l l cle­ e Ante Room, Buffer Room, and Clean Room" (Undated) does not include
    requirements for the contact time fo • ~ r W)JHdisinfectants. The labeling for the products documents a llmoute
    contact time.

    B) The-and ~disinfectants are not~

    C) Your finn does not routinely use a sporicidal agent in the ISO 5 or 7 areas. In addition, SOP #5.002 has no requirements
    for the use ofa sporicidal agent.

    OBSERVATION 8

    The labels of your outsourcing facility's drug products are deficient.

    Specifically the labels do not include information required by section 503B(a)(lOXA) and (B).

    For example, yow· drug product labels do not contain the following:

    I) The statements "This is a compounded drug" and "Office Use Only"


    2) The date the drug was compounded.

    In addition, the following information is not included on container labels for some drug products you produce:

    I. Information to facilitate adverse event reporting: www. fda.gov/medwatch and 1-800-FDA-1 088
    DEPARTMENT OF HEALm AND HUMAN SERVICES
    FOOD AND DRUG ADMIN1STRATION
    DllllUCT ADilftESS I>KJ I'HCliE NUioiiiER

    4040 North Central Expressway, Suite 300 05/28/2015 - 06/05/2015*


    FEJ~
    Dallas, TX 75204
    (214) 253- 5200 Fax: (214) 253- 5314 301104 3554
    Industry ~nformation: www.fda . gov/oc/industry
    NAtoE N«:J nn.e OF IOCliYICJUo4ll. ro W\ftOMI'Iei'QftT 156UfD
    Luis Ricardo de Leon, Executive Officer and Pharmacist in Charge
    ·-­
    TO :

    Pharm D Solutions, LLC


    err . STATE.llP CODE. COUNll<1
    tTRUT AOORESS

    1304 S Loop W
    ~ ESTAIIUSHIEHT INSPECfEO

    Houston, TX 77054-4010 Outsourcing Facility

    2. Directions for use including as appropriate, dosage and administration.

    Examples of drug product labels which do not have this information include the following:

    A) "Epinephrine 1:1000 0.2ml 0.2mg Injectable" (Epinephrine, USP 1mgfml), Jot #0526150 I-JDL (Production date:
    5/27/2015, Expiration: 6124/15)
    B)"Columbus Quad Opthalmic Compound Opthalmic" (Ketorolac Tromethamine, USP 0.5%, Phenylephrine HCL, USP
    2.5%, Tropicamide, USP l.OOAI, Tetracaine HC~ USP 0.5%), lot #05261503-JDL (Production date: 5127120 15, Expiration:
    06124/ 15)
    C) "Vigamox Opthalmic Solution" (Moxifloxacin 0.5% (base), USP), lot #05261502-JDL (Production date: 51271201 5,
    Expiration: 06/24/ 15)

    * DATES OF INSPECTION:
    05/281201 5(Thu), 05/29/20IS(Fri), 06/0112015(Mon), 06/02120IS(Tue), 06/05/20I5(Fri)

    £IMI\.OYU(8) -'1\JRE

    SEE REVERSE Stephen D. Brown , Investigator


    06/05/2015
    OF THIS PAGE
    FORM FDA 483 (09/01) INSI,ECI'IONAL OBSERVATIONS PAGE 4 OF 4 PAGES

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