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

*August 3 update: we added 2 additional warning letters that were released by the FDA after we published this post on July 12, 2017.*

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “misbranded products” to sites “failing to investigate the unexplained discrepancy.”

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

  • ChemRite CoPac, Inc., Lannon, WI – 3 violations:
    • The firm failed to maintain adequate separate defined areas necessary to prevent contamination or mix-up (21 CFR 211.42(c)).
    • The firm does not have, for each batch of drug product, appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable organisms (21 CFR 211.165(b)).
    • 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, including drug products manufactured, processed, packed or held under contract by another company (21 CFR 211.22(a)).
  • Everwell Specialty Pharmacy, Pensacola, FL – 3 violations:
    • Drug products produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a]
    •  The firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(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)).
  • Shandong Analysis and Test Center., Jinan, Shandong, China – 2 violations:
    • Failure to ensure that test procedure is scientifically sound and appropriate to ensure that your API conform to established standards of quality and/or purity.
    •  Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.
  • Raritan Pharmaceuticals, Inc., East Brunswick, NJ – 3 violations:
    • The firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. (21 CFR 211.84(d)(2))
    • The firm does not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality and/or purity they purport or are represented to possess. (21 CFR 211.100(a))
    • The firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet its specifications, whether or not the batch has already been distributed. (21 CFR 211.192)

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  • AndroPharm LLC, Boca Raton, FL – 1 violation:
    • Failed to bear adequate directions for the products’ intended uses; therefore, the products are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
  • Hardcore Formulations, Kyle, TX – 1 violation:
    • Failed to bear adequate directions for the products’ intended uses; therefore, the products are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
  • Prestige Brands Holdings, Inc., Tarrytown, NY – 1 violation:
    • The firm failed to fulfill its listing obligations under Section 510(j) of the FD&C Act, [21 U.S.C. 360(j)], which is a prohibited act under Section 301(p) of the FD&C Act, [21 U.S.C. 331(p)]. In addition, the firm’s failure to fulfill its listing obligations misbrands the product under Section 502(o) of the FD&C Act [21 U.S.C. 352(o)].Introduction or delivery for introduction into interstate commerce of a misbranded product is a prohibited act under Section 301(a) [21 U.S.C. 331(a)].

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