FDA Sent These 8 Warning Letters for Pharma Companies | March 2017

We took a snapshot of the 8 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to monitor the water purification system to personnel not wearing appropriate clothing to prevent contamination.

From pharmaceuticals in California, Singapore, and more, here they are:

  • Badrivishal Chemicals & Pharmaceuticals, Maharashtra, India – 4 violations:
    • Failure to validate and monitor the water purification system to ensure that water is of appropriate quality and suitable for its intended use.
    • Failure of quality unit to prepare, review, and approve documents related to the manufacturing of API.
    • Failure to verify the suitability of analytical methods.
    • Failure to adequately investigate critical deviations.
  • Cape Fear Naturals, LLC, Wilmington, NC – 5 violations:
    • Failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. During the inspection, site acknowledged to investigator that site does not have written procedures.
    • Failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. During the inspection, site acknowledged to investigator that site does not have written quality control procedures.
    • Did not establish and follow written procedures to review and investigate product complaints, as required by 21 CFR 111.553. Specifically, site does not have any written procedures for handling, investigating, and recording product complaints.
    • Failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. During the inspection,  acknowledged to investigator that site does not have written procedures.
    • Failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. During the inspection, acknowledged to investigator that site does not have written procedures for in-house labeling of dietary supplements sold by firm.

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  • Lumis Global Pharmaceuticals Co. Ltd., Wuhan, China – 3 violations:
    • Failure to transfer all quality or regulatory information received from the API manufacturer to site customers.
    • Failure to control the API repackaging, relabeling, and holding operations in order to avoid mix ups and loss of API identity.
    • Failure of site quality unit to exercise its responsibility to ensure the API relabeled at site facility are in compliance with CGMP.
  • Opto-Pharm Pte Ltd., Singapore, Republic of Singapore – 3 violations:
    • Firm 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)).
    • Firm failed to establish the reliability of the container-closure supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals (21 CFR 211.84(d)(3)).
    • Firm failed to ensure that drug products bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
  • Chen Shwezin, Westlake Village, CA – 6 violations:
    • Firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).
    • Firm 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)).
    • Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
    • Firm 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)).
    • 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)).
    • Firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).
  • USV Limited, Govandi, Mumbai India – 4 violations:
    • Firm 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)).
    • Firm 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)).
    • Firm 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)).
    • Firm 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)).
  • South Coast Speciality Compounding Inc, Irvine, CA – 1 violation:
    • Drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing drug products to be adulterated under.
  • Indoco Remedies Limited, Verna, Goa, India – 2 violations:
    • Firm failed to establish and follow 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).
    • Firm has failed to ensure the responsibilities and procedures applicable to quality control unit are followed (21 CFR 211.22(d)).

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