FDA Sent These 9 Warning Letters for Pharma Companies | July 2017

We took a snapshot of the 9 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “adulterated and misbranded drug products” to sites “failing to sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination.”

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

  • Skin Sciences Laboratory, Inc., Pasig City, Philippines – 4 violations:
    • The site methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
    • The site manufactures and distributes unapproved new drugs in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Additionally, FDA has determined that one of the drug products manufactured is misbranded in violation of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
    • The site 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)).
    • The site failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)).
  • Village Pharmacy, Allentown, NJ – 5 violations:
    • Failed to meet the conditions of section 503A by not receiving valid prescriptions for individually-identified patients for a portion of the drug products produced.
    • The site 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)).
    • The site 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)).
    • The site 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)).
    • Product labeling fails to bear adequate directions for their intended uses: 502(f)(1) of the FDCA (seee.g., 21 CFR 201.115) therefore, drug products are misbranded under section 502(f)(1) of the FDCA.
  • Medical Center Pharmacy, Inc., Cleveland, TN- 9 violations:
    • The site failed to meet the conditions of section 503A by not receiving valid
      prescriptions for individually-identified patients for a portion of the drug products produced.
    • The site failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21CFR 211.42(c)(10)(v)].
    • The site 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)].
    • The site failed to establish an adequate system for monitoring environmental conditions in the aseptic processing area [21 CFR 211.42(c)(10)(iv)].
    • The site 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)].
    • The site failed to adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups [21 CFR 211.42(b)].
    • The site failed to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed [21 CFR 211.192].
    • The site failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination [21 CFR 211.28(a)].
    • Product labeling fails to bear adequate directions for their intended uses: 502(f)(1) of the FDCA (seee.g., 21 CFR 201.115) therefore, drug products are misbranded under section 502(f)(1) of the FDCA.

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  • Option Care., Columbia, MD – 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 section 501(a)(2)(A) of the FDCA.
  • W & C Apothecary, dba The Apothecary, Sartell, MN – 7 violations:
    • Failed to meet the conditions of section 503A by not receiving valid prescriptions for individually-identified patients for a portion of the drug products produced.
    • 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 section 501(a)(2)(A) of the FDCA.
    • The site failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c) (10)(vi)).
    • The site 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)).
    •  The site failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
    • The site failed to reject drug products that did not meet established standards or specifications and any other relevant quality control criteria (21 CFR 211.165(f)).
    • Labeling fails to bear adequate directions for their intended uses, and they are not exempt from the requirements of section 502(f)(1) of the FDCA (seee.g., 21 CFR 201.115). Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FDCA. It is a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.
  •  Algunas, Inc. DBA Woodland Hills Compounding Pharmacy.,Woodland Hills, CA – 5 violations:
    • Failed to meet the conditions of section 503A by not receiving valid prescriptions for individually-identified patients for a portion of the drug products produced.
    • The site 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).
    • No FDA-approved applications on file for the ineligible drug products that were compounded. Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. § 331(d)]
    •  Product labeling fails to bear adequate directions for their intended uses: 502(f)(1) of the FDCA (seee.g., 21 CFR 201.115) therefore, drug products are misbranded under section 502(f)(1) of the FDCA.
    • The site failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).
  • Sage Products, Inc., Cary, IL – 3 violations:
    • The site failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
    • The site failed to establish scientifically sound and appropriate sampling plans and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
    • The site  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 malfunction 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)).
  • Tubilux Pharma S.p.A., Rome, Italy – 2 violations:
    • The site failed to use equipment in the manufacture, processing, packing, or holding of drug products that are of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
    • The site 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)).
  • Vista Pharmaceuticals Limited, Hyderabad, India 2 violations:
    • The Site 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)).
    • The site failed to establish 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))

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