Warning Letters

FDA Sent These 5 Warning Letters for Pharma Companies | December 2016

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to put expiration dates on containers to failing to put soap in the bathrooms.

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

  • Horizon Pharmaceuticals, Inc., Riviera Beach, FL – 3 violations:
    • Failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
    • Failed to thoroughly investigate any unexplained discrepancy or failure of a batch, or any of its components, to meet any of its specifications, whether or not the batch was already distributed (21 CFR 211.192).
    • Failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
  • Intega Skin Sciences, Inc., Laval, Canada – 5 violations:
    • Failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, and extend investigations to other batches of drug product that may have been associated with the specific failure or discrepancy. (21 CFR 211.192)
    • Failed to establish written responsibilities and procedures applicable to the quality control unit. (21 CFR 211.22(d))
    • Failed to ensure that equipment is cleaned at appropriate intervals to prevent contamination and that adequate written cleaning procedures are established. (21 CFR 211.67)
    • Failed to establish adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with 21 CFR 211.192. (21 CFR 211.198)
    • Failed to establish adequate written procedures for production and process control 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))
  • Aplicare, Inc., Meriden, CT – 4 violations:
    • Failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
    • Failed to use appropriate air filtration systems for production areas (21 CFR 211.46(c)).
    • Failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).
    • Failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).
  • Natura Bisse International S.A., Barcelona, Spain – 3 violations:
    • Failed to 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)).
    • Failed to ensure that its drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
    • Failed to follow required laboratory control mechanisms, including any changes made to them, which were drafted by the appropriate organizational unit and reviewed and approved by the quality control unit (21 CFR 211.160(a)).
  • Baoying County Fukang Medical Appliance Co., Jiangsu Province, China – 6 violations:
    • Firm delayed, denied, or limited an inspection, or refused to permit the FDA inspection.
    • 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))
    • 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))
    • Firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin. (21 CFR 211.56(a))
    • Firm failed to provide adequate washing facilities, including hot and cold water, soap or detergent, air driers or single service towels, and clean toilet facilities easily accessible to working areas. (21 CFR 211.52)
    • Firm failed to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures. (21 CFR 211.80(a))

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