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    Shlok Dixit
    A warning letter was issued by the FDA to Aplicare, Inc. in December 2016 regarding violations found during an inspection. The FDA found that Aplicare failed to follow proper procedures to prevent microbial contamination of their sterile povidone-iodine drug products. Specifically, Aplicare did not adequately validate their sterilization process and failed to prevent recurring contamination incidents in sterility tests. They also lacked appropriate testing and manufacturing controls to ensure sterility throughout the products' 36-month expiration period.

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    PME

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    Shlok Dixit
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    A warning letter was issued by the FDA to Aplicare, Inc. in December 2016 regarding violations found during an inspection. The FDA found that Aplicare failed to follow proper procedures to prevent microbial contamination of their sterile povidone-iodine drug products. Specifically, Aplicare did not adequately validate their sterilization process and failed to prevent recurring contamination incidents in sterility tests. They also lacked appropriate testing and manufacturing controls to ensure sterility throughout the products' 36-month expiration period.

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    A warning letter was issued by the FDA to Aplicare, Inc. in December 2016 regarding violations found during an inspection. The FDA found that Aplicare failed to follow proper procedures to prevent microbial contamination of their sterile povidone-iodine drug products. Specifically, Aplicare did not adequately validate their sterilization process and failed to prevent recurring contamination incidents in sterility tests. They also lacked appropriate testing and manufacturing controls to ensure sterility throughout the products' 36-month expiration period.

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    PME

    Uploaded by

    Shlok Dixit
    A warning letter was issued by the FDA to Aplicare, Inc. in December 2016 regarding violations found during an inspection. The FDA found that Aplicare failed to follow proper procedures to prevent microbial contamination of their sterile povidone-iodine drug products. Specifically, Aplicare did not adequately validate their sterilization process and failed to prevent recurring contamination incidents in sterility tests. They also lacked appropriate testing and manufacturing controls to ensure sterility throughout the products' 36-month expiration period.

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    A warning letter was issued in December 15, 2016 by the FDA to

    Mr. Andrea F. Sama, Plant Manager of Aplicare, Inc. which describes


    about the violations of manufactured pharmaceuticals. According to
    FDA the firm failed to follow appropriate written procedures that are
    designed to prevent microbiological contamination of drug products
    purporting to be sterile.

    Based on their labeling, Aplicare’s Povidone-Iodine products are


    “drugs” as defined under section 201(g)(1)(B) of the FD&C Act (21
    U.S.C. 321(g)(1)(B)), because they are intended for the diagnosis, cure,
    mitigation, treatment, or prevention of disease, and/or under section
    201(g)(1)(C) of the FD&C Act (21 U.S.C. 321(g)(1)(C)) because they are
    intended to affect the structure or any function of the body of a
    person. Specifically, these products are intended as topical antiseptics
    and antifungals.

    In this letter FDA listed four major violation of the firm. Firstly,
    they failed to follow appropriate written procedures that are designed
    to prevent microbiological contamination of drug products purporting
    to be sterile. According to FDA the firm cannot validate their process
    and the claim that it achieves “sterilization” as they cannot implement
    adequate microbial control for povidone-iodine drug products, which
    should be sterile. The process of sterility relies on (b)(4) which is used
    as a biological indicator organism as it is found to be less resistant
    than organisms routinely found in the manufacturing environment,
    such as Bacillus licheniformis, but they failed to characterize the anti-
    microbial effects on (b)(4), which assess biological indicator organism
    suitability. Further, after repeated warning about the spore-forming
    microorganisms found in sterility test since at least 2012, found in
    sterility test, they failed to prevent the recurrence of these
    contamination incidents. They assured the FDA about the quality
    control and wanted a 14 to 18 months’ time period for revalidation but
    failed to give any fruitful result.
    They also failed to test numerous product lots for sterility using
    USP <71> or an equivalent method and instead used a surrogate
    sterility test that lacks a representative sample of the batch and is
    insufficiently sensitive. Neither they have a classified area for the
    manufacturing of povidone-iodine drug product that purport to be
    sterile, nor they have any separate or defined areas which are
    necessary to prevent contamination or mix-ups. This level of
    monitoring is insufficient to protect the drug and its packaging
    components during production, even to evaluate whether the
    manufacturing environment is in control. For instance, the (b)
    (4) samples collected in March 2015 by FDA were identified
    as Bacillus species, which are spore-forming bacteria.

    Lastly, the firm failed to establish and follow an adequate written


    testing program designed to assess the stability characteristics of
    drug products. As they failed to test the sterility of the product, there
    is no assurance that the povidone-iodine drug products can meet their
    specifications for sterility through their 36-month expiration period.

    The study of these violations is crucial so as to know the faults


    and the otherwise results of using the unapproved FDA drugs and the
    improvements that can be made in the manufacturing operation that
    will establish a high level of sterility assurance.

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