FDA Sent These 11 Warning Letters for Pharma Companies | August 2017

We took a snapshot of the 11 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to keep drug product infestation free to failing to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the proper education, training, and experience.

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

  • Carlton’s Dunwoody Pharmacy Corporation, Dunwoody, GA – 6 violations:
    • Drug products produced failed to meet the conditions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a] for exemption from certain provisions of the FDCA. Specifically, the investigators noted that site did not receive valid prescriptions for individually-identified patients for a portion of the drug products site produced.
    • The firm 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)).
    • Firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)).
    • The firm 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).
    • The firm used instruments, apparatus, gauges, and/or recording devices that did not meet established specifications (21 CFR 211.160(b)(4)
    • The ineligible drug products compounded are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their 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 (see, e.g., 21 CFR 201.115). These ineligible drug products are misbranded under Section 502(f)(1) of the FDCA. 
  • Hetero Labs Limited, Hyderabad, India – 3 violations:
    • The firm 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).
    • The firm 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 firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).
  • Bicooya Cosmetics Limited, Yiwu Zhejiang, China – 4 violations:
    • The firm failed to keep the buildings used in the manufacture, processing, packing, or holding of a drug product free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)).
    • The firm 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 firm 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)).
    • The firm 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).  
  • C K Solutions, Inc. (dba Wind River Herbs), Thayne, WY – 11 violations:
    • The firm 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103.
    • The failed to establish specifications for any points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a).
    • The firm failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that site manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch as required by 21 CFR 111.205(a).
    •  Firm batch production records (BPRs) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. 
    • The firm failed to establish and follow written procedures to fulfill the requirements related to packaging and labeling operations, as required by 21 CFR 111.403. 
    • The firm failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. 
    •  The firm failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplement, as required by 21 CFR 111.503.  
    • The firm failed to establish and follow written procedures for holding and distribution operations, as required by 21 CFR 111.453. 
    •  The firm failed to establish and follow written procedures for cleaning the physical plant and for pest control, as required by 21 CFR 111.16.
    • Firm failed to establish and follow written procedures for  fulfilling the requirement for equipment and utensils, including written procedures for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.25(c). 
    • Misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101.

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  • Pharmacy Plus, Inc. dba Vital Care Compounder, LLC, Hattiesburg, MS – 7 violations:
    • Drug products produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a]
    • The firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).
    • The 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)).
    • The 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)).
    • The firm failed to establish time limits for the completion of each phase of production to assure the quality of the drug product (21 CFR 211.111).
    • The firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
    • The 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)).
  • ImprimisRx PA, Inc., dba ImprimisRx, Folcroft, PA  – 2 violations:
    • The firm’s cleaning and disinfecting procedures for work surfaces and utensils used for beta-lactam products are inadequate. 
    • The firm’s controls to prevent cross-contamination of beta-lactam drugs with other products during production are insufficient. 
  • Maple Rose Enterprises, Inc. dba Pencol Compounding Pharmacy, Denver, CO – 9 violations:
    • Drug products produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a] 
    • Failure to label adequate directions for use, and the requirement of compliance with CGMP under section 501(a)(2)(B) of the FDCA. 
    • 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 manufactured drug products to be adulterated under section 501(a)(2)(A) of the FDCA [21 U.S.C. § 351(a)(2)(A)]. 
    • Significant CGMP violations at the facility, causing the ineligible drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)].
    • The 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)). 
    • The 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)).
    • The firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug products from contamination (21 CFR 211.28(a)).
    • The firm failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (21 CFR 211.58).
    • The 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)). 
  • Homeolab USA Inc., Montreal, QC, Canada – 2 violations:
    • The firm 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)).
    • The firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and (2)). 
  • Cellex-C International Inc., Toronto, Ontario Canada – 5 violations:
    • The firm 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)).
    • The firm 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)).
    • The firm failed to establish written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).
    • The firm failed to establish adequate written procedures for production and process control designed to assure that the drug products the site manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). 
    • The firm 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). 
  • Ballard Plaza Pharmacy I, Inc., Seattle, WA – 5 violations:
    • Failure to label with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].
    • 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).
    • The firm failed to meet the conditions of section 503A.  For example, the investigators noted firm did not receive 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 the manufactured drug products to be adulterated under section 501(a)(2)(A) of the FDCA.
    • Drug products compounded are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely; their 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, these ineligible drug products are misbranded under section 502(f)(1) of the FDCA. 
  • Foshan Flying Medical Products Co., Ltd., Foshan City,  China – 6 violations:
    • The firm 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)).
    • The firm 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)).
    • The firm failed to 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 firm 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)).
    • The firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced and to maintain such records for at least one year after the expiration of the batch (21 CFR 211.188 and 211.180(a)).
    • The firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)).

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