FDA Sent These 5 Warning Letters for Pharma Companies | September 2017

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from sites failing to establish adequate quality control to failing to label products to bear adequate directions for use.

From pharmaceuticals in China, New Mexico, and more, here they are (starting with the most recent):

  • Shandong Vianor Biotech Co., Ltd., Linyi Shandong, China – 3 violations:
    • The firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
    • The firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
    • The firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
  • Magellan Rx Pharmacy, LLC, Astoria, NY – 1 violation:
    • Drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.
  • HomeoCare Laboratories, Inc., Yonkers, NY – 7 violations:
    • Sites methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, sites drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
    • The firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).
    • The firm failed to establish and follow adequate written procedures designed to assure batch uniformity and integrity of drug products that describe the in-process controls, and tests or examinations to be conducted on appropriate samples of in-process materials of each batch (21 CFR 211.110(a)).
    • The firm failed to conduct at least one test to verify the identity of each component of a drug product. The firm also failed to establish the reliability of component supplier analyses on which site rely in lieu of certain tests through appropriate validation of the supplier’s test results at appropriate intervals (21 CFR 211.84(d)(1) & (2)).
    • The firm failed to maintain written records so that data therein could be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures (21 CFR 211.180(e)). 
    • Products’ not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. Therefore, these products are subject to section 503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)) and are misbranded under section 503(b)(4) of the FD&C Act (21 U.S.C. 353(b)(4)) in that their labels fail to bear the symbol, “Rx only.”
    • Products’ labeling fails to bear adequate directions for use for this indication, which causes the products to also be misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)). It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the FD&C Act (21 U.S.C. 331(a)).

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  • Wuxi Medical Instrument Factory, Wuxi City, Jiangsu, China – 5 violations:
    • Site methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, sites drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
    • The firm failed to establish written procedures for production and process controls designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
    • The firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
    • The firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
    • The firm failed to maintain adequate written records of major equipment maintenance (21 CFR 211.182).
  • Nova Homeopathic Therapeutics, Inc., Albuquerque, NM – 4 violations:
    • The firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products (21 CFR 211.22(a)).
    • The firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to test each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) & (2)).
    •  The firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
    • Products’ labeling fails to bear adequate directions for use for these indications, which causes the products to also be misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)). It is a prohibited act to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the FD&C Act (21 U.S.C. 331(a)).

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