Week of Apr 22nd 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 new warning letters this week:

  • The Center for Tobacco issued 3 of them
  • 1 warning letter went to an API manufacturer
  • 2 warning letters were issued to finished pharmaceuticals manufacturers of OTC products


  • Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd (Yunnan, China) received a warning letter on April 19th 2018 based on the outcome of an inspection ending October 20th 2017. The firm is an API manufacturer. The FDA placed them on Import Alert 66-40 on February 8th 2018. They must address the ‘long firm’ of FDA boilerplate follow up actions to egregious data integrity deficiencies. Deficiencies include but are not limited to:
    • Laboratory equipment did not have controlled restricted access. All users could delete or modify data, and there was no way to track who did any of the actions because all users shared the same password. The same problem was identified in 2015, and the firm has not implemented any of the promised corrective actions.
    • The firm was unable to provide electronic data for FDA to compare with the paper data packages. The firm “could not provide the electronic data from laboratory analyses on this equipment for the above period of several years. You explained that the electronic data in question had been deleted by accident and was no longer available.”    
    • Not all laboratory data were included in the data packages used to release products.
    • The Q unit approved the CoA before testing was completed.

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  • Degasa S.A. De C. V. (Mexico) received a warning letter on April 18th 2018 based on the outcome of an inspection ending September 8th 2017. The firm manufactures OTC products. Deficiencies include but are not limited to:
    • The firm has not implemented adequate microbiological testing of drug products. The firm did not perform microbial testing for 1 product developed to prepare skin prior to surgery, or prevent infections, or help reduce bacteria. The firm is to provide the following:
      • “An action plan for promptly testing retain samples of all batches in the U.S. market that are still within expiry to determine their microbial quality. These tests should be performed and results provided to the FDA within 30 days of receipt of this letter. Include complete analytical records for each of these tests, and full information on the name and location of the testing laboratory performing the analyses. If any test results reveal that you released drug products that did not meet appropriate microbial specifications, specify the corrective actions you have taken or will take, including notifying customers or recalling products.
      • For each of your drug products, provide microbiological test methods and finished product release specifications for microbiological quality. Include tests for either microbial limits (i.e., total counts and objectionable microbes) or sterility, depending on the intended use of the product.
      • Provide validation studies for each microbiological testing method (e.g., microbial limits, sterility, antimicrobial effectiveness) used for your drug products.
      • Provide an independent, comprehensive assessment of the manufacturing operations used to manufacture each of your topical drug products, with special emphasis on material inputs, enhanced bioburden controls, and contamination prevention.” 
    • The firm could not provide complete raw data to support qualification of the water system. Further, the lab lacked data such as weight of samples, test methods, and records of calculations — all in addition to the lack of data on water testing. The firm is to provide the following to FDA in their response:
      • “A comprehensive independent evaluation of the water system design, including a thorough corrective action and preventive action plan (CAPA) to install and validate a suitable water system.
      • An effective program for ongoing control, maintenance, and routine monitoring that ensures the remediated system consistently produces water that meets USP Purified Water monograph specifications and appropriate microbial limits. Regarding the latter, your topical products necessitate significantly tighter total count action limits than those currently used by your firm.
      • Investigation of the missing water system data, including root causes, and your CAPA plan. Include a risk assessment of the impact on product quality of using water from this system in the manufacture of your drug products.
      • A retrospective review of both in-process and finished product test results to determine where product quality may have been compromised due to your practice of not maintaining complete analytical data.
      • A comprehensive assessment of the documentation systems used throughout your manufacturing and laboratory operations to determine where else you lack complete records. Include a detailed CAPA plan with systemic remediations to assure your facility maintains complete records. The CAPA should include, but not be limited to, revised procedures, training, and systemic actions implemented to assure integrity of all CGMP records.”
    • The firm’s quality unit does not exercise their authority.
  • Phase 4 Pharmaceutical, LLC (Aventura, FL) received a warning letter on April 18th 2018 based on the outcome of an inspection ending May 2nd 2017. The warning letter addressed repackaging and labeling of OTC drug products.
    • The firm lacks a quality unit as well as written procedures for repackaging operations/quality unit responsibilities.
    • The repackaging process does not have adequate controls to prevent product mix-ups.
    • The firm did not have procedures to describe the drug distribution system. For example, lot numbers are not documented for products distributed and, thus, cannot trace products thru the marketplace.
    • The repackaged OTC transdermal patches packed in zip lock bags do not bear an expiry date.
    • Further, “FDA testing of your drug products – Power Patch, Female Libido Formula Patch, DHEA Skin Patch for Men, and Skin Patch for Women – found multiple samples to be subpotent with no active ingredient content. In addition, FDA testing found nondeclared ingredients (DHEA and pregnenolone), in samples of your Power Patch.”

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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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