FDA Sent These 15 Warning Letters for Pharma Companies | December 2017

//FDA Sent These 15 Warning Letters for Pharma Companies | December 2017

FDA Sent These 15 Warning Letters for Pharma Companies | December 2017

By | 2018-02-01T16:35:03+00:00 February 1st, 2018|FDAzilla|

We took a snapshot of the 15 warning letters (yes, 15) the FDA sent to pharmaceutical companies in December.  Drug manufacturing violations ranged from failing to establish and follow adequate written procedures to failing to reveal consequences that could result from the use of a drug.

From pharmaceuticals in San Diego, Korea, and more, here they are (starting with the most recent):

  • Investra-24hs – 1 violation:
    • The websites offer unapproved new drugs and misbranded drugs for sale in violation of sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]
  • Imprimis Pharmaceuticals Inc., San Diego, CA – 2 violations:
    • Failed to present any information regarding the risks associated with products, the website is false or misleading.
    • Failed to reveal facts that are material in light of representations made or with respect to consequences that may result from the use of the drug.
  • Schrofner Cosmetics, Salzburg, Austria – 4 violations:
    • Failed to establish an adequate quality control unit and procedures applicable to the 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) and (d)).
    • Failed to establish and follow adequate written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186(a)).
    • 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 test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality (21 CFR 211.84(d)(1) & (2)).
  • C.O. Truxton, Inc., Bellmawr, NJ – 5 violations:
    • Failed to establish a 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)).
    • Failed to establish and follow written procedures to assure that correct labels and packaging materials are used for drug products (21 CFR 211.130).
    • Failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product (21 CFR 211.198(a).
    • Failed to establish a written distribution procedure to include a system by which each lot of drug product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).
    • Failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

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  • Delta Laboratories Pty. Ltd. Somersby, Australia – 3 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 (21 CFR 211.192).
    • 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)).
    • Failed to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
  • Deserving Health International Corp., Richmond, Canada – 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 establish an adequate quality control unit and procedures applicable to the 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) and (d)).
    • Failed to test each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) & (2)).
    • Failed to perform, 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, and conduct appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and (b)).
  • Prosana Distribuciones, Iztacalco, Mexico – 4 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 establish the reliability of component supplier analyses on which company relies in lieu of certain tests through appropriate validation of the supplier’s test results at appropriate intervals (21 CFR 211.84(d)(1) and (2)).
    • Failed to prepare batch production and control records for each batch of drug product that include complete documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, including a statement of the actual yield, and a statement of a percentage of theoretical yield at appropriate phases of processing. (21 CFR 211.188(b)(7)).
    • 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)).
  • Fresenius Kabi AG (Baddi), Germany – 1 violation:
    • 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 (21 CFR 211.192).
  • Wuhan Chinese Moxibustion Technology Dev. Co., Wuhan, China – 5 violations:
    • Failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(a) and (d)).
    • Failed to prepare master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186(b)).
    • 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)).
    • 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)).
    • 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)).
  • AN Co., Gyeonggi-do, Korea – 3 violations:
    • Failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any specifications, whether or not the batch has already been distributed (21 CFR 211.192).
    • Failed to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
    • Failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)).
  • Amaros Co., Seongnam-si, Korea – 2 violations:
      • Failed to establish adequate written responsibilities and procedures applicable to the quality control unit. (21 CFR 211.22(a) and (d)).
      • Failed to have written procedures describing the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials, which shall be representatively sampled, examined or tested upon receipt and before use in packaging or labeling of a drug product (21 CFR 211.122(a)).
  • Buffalo Pharmacies, Inc., Buffalo, NY – 4 violations:
    • Failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).
    • 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 establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
    • Failed to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure in the aseptic processing areas (21 CFR 211.42(c)(10)(iii)).
  • Seindni Co., Seoul, Korea – 1 violation:
    • Failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(a) and (d)).
  • Shanwei Honghui Daily Appliance Co., Shanwei, China – 5 violations:
    • 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)).
    • Failed to follow 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, and to document same at the time of performance (21 CFR 211.100(b)).
    • Failed to perform, 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, and conduct appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and (b)).
    • Failed to ensure the identity of components, including active ingredients and excipients from various suppliers (21 CFR 211.84(d)(1) and (2)).
    • Failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
  • Fresenius Kabi, Germany, 2 violations:
    • Failure to adequately investigate and document out-of-specification results according to a procedure.
    • Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that raw materials, intermediate and API conform to established standards of quality and purity.

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