Warning Letters

FDA Sent These 6 Warning Letters for Pharma Companies | October 2016

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from allowing unauthorized access to confidential data to forgetting to put expiration dates on drugs.

From 3 pharmaceuticals in the USA and 3 abroad, here they are (starting with the most recent):

  • Beijing Taiyang Pharmaceutical Industry Co., Beijing, China – 4 violations:
    • Firm delayed, denied, or limited an inspection, or refused to permit the FDA inspection.
    • Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.
    • Failure to ensure that all quality-related activities are recorded at the time they are performed.
    • Failure to maintain batch production and laboratory control records to determine compliance with established API specifications before a batch is released or distributed.
  • Interpharm Praha A.S., Modrany, Czech Republic – 4 violations:
    • Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.
    • Failure to ensure that test procedures are scientifically sound and appropriate to ensure that API conform to established standards of quality and/or purity.
    • Failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records (21 CFR 211.68(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)).
  • JD & SN Inc., Moses Lake, WA – 6 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 ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination [21 CFR 211.28(a)].
    • Failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas [21 CFR 211.42(c)(10)(iv)].
    • Failed to establish and 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)].
    • Firm does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product [21 CFR 211.167(a)].
  • Teva Pharmaceutical Works Pvt. Ltd., Petah Tikva, Israel – 7 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 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 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 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))
    • Failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. (21 CFR 211.68(b))
    • Failed to 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))
  • Vetix, Inc., Lexington, KY – 6 violations:
    • Failed to establish in writing and fully follow certain responsibilities and procedures applicable to the quality control unit [21 CFR § 211.22(d)].
    • Failed to ensure testing of drug product which includes appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release. [21 CFR § 211.165(a)].
    • Failed to ensure drug products bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. [21 CFR § 211.137(a)].
    • Failed to ensure there are written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. [21 CFR § 211.100(a)].
    • Failed to ensure that the establishment of specifications including any changes thereto, are drafted, reviewed and approved by the appropriate organizational unit. [21 CFR § 211.160(a)].
    • Failed to ensure that the reserve sample of drug product consists of at least twice the quantity necessary to perform all the required tests of drug product. [21 CFR § 211.170(b)].
  • SaveWay Compounding Pharmacy, Inc., Newark, DE – 6 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 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 ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination [21 CFR 211.28(a)].
    • Failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas [21 CFR 211.42(c)(10)(iv)].
    • Failed to establish and 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)].
    • Failed to review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. [21 CFR 211.192].

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