FDA Sent These 5 Warning Letters for Pharma Companies | June 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):

  • 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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