Week of May 20th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 12 warning letters this week. Many were issued for unapproved new drugs/misbranding deficiencies. We address 4 below that focused on GMP deficiencies.


  • Emmett F. Branigan MD PS Inc (Bellingham, WA) received a warning letter dated May 7th 2018 based on the outcome of an inspection ending January 31st 2018. Though not stated directly, it appears that the firm collects/processes and administers assisted reproductive tissues and cells. The firm did not respond to the form-483, hence the warning letter. Most deficiencies are associated with failure to adequately test tissues/cells for infectious agents including hepatitis B, Zika virus, HIV-1, HCV, and WNV and failure to maintain/review adequate medical records of donors.

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  • Cerno Pharmaceuticals LLC (Miami, FL) received a warning letter on May 15th 2018 based on the outcome of an inspection ending November 17th 2017. The firm manufactures OTC drug products. FDA suggests they hire a qualified consultant to help them come into GMP compliance. In addition to the GMP deficiencies, the warning letter also identifies that the drugs are misbranded. Deficiencies include but are not limited to:
    • Use of raw materials in manufacturing drug products before they have been tested and released by the Quality Unit.
    • The firm did not follow their own procedures requiring a major cleaning after rooms have been idle for extended periods of time.
    • The firm does not have equipment logs for all major pieces of equipment.
  • Nox Bellcow Cosmetics Co., Ltd (Guangdong, China) received a warning letter on May 9th 2018 based on the outcome of an inspection ending September 22nd 2017. The firm was placed on Import Alert 66-40 on December 27th 2017.
    • The Quality Unit released products for distribution before all test results were available. Further, the Quality unit did not have adequate systems and documentation to oversee change control, QC testing practices, batch review, and annual product review. The first is asked to provide the following in response to the letter:
      • “Conduct a retrospective review of all assay results for active content used to manufacture drug product currently in the U.S. market to determine if the specification was met. If you identify out-of-specification (OOS) results, describe the actions you have taken or will take to ensure the quality of marketed products and protect patients, including notification of customers and recalls.
      • Provide an independent, comprehensive assessment of the documentation systems used throughout your manufacturing and laboratory operations to determine where else you lack complete records. Include a detailed corrective action and preventive action (CAPA) plan with systemic remediations to assure your facility maintains complete records.
      • Obtain an independent, comprehensive assessment of your quality unit. Provide a thorough CAPA that fully remediates your quality unit, including but not limited to procedures that detail appropriate responsibilities and authorities (e.g., final review of all production and control records before a final batch disposition decision) of your quality unit.”
    • The firm did not test APIs used in manufacturing of drug products but rather accepted them based on their appearance and odor and the supplier’s CoA. The firm is to provide the following in response to the warning letter:
      • “Provide your procedure for incoming component testing. Include a commitment to conduct at least one specific identity test for each incoming component (both active and inactive ingredients) lot.
      • Describe in detail how you plan to test each incoming component lot for conformity with all appropriate written specifications for purity, strength and quality. If you accept your suppliers’ CoA in lieu of testing each component lot for purity, strength, and quality, specify how you plan to establish the reliability of your suppliers’ test results for these attributes through periodic validation.”
    • The cleaning validation failed multiple rinse samples when tested for residual disinfectant. At first, the firm simply ignored these ‘extra’ peaks but did integrate them during the inspection. The firm is to provide the following in response to the warning letter:
      • An assessment of the impact of residual cleaning agents on the quality of your drug product.
      • Your plan of action, with timelines, to develop and implement an appropriate cleaning validation program for your manufacturing equipment. Your program should include appropriate procedures to assure that your cleaning results comply with established acceptance criteria.
      • A comprehensive, independent assessment of your overall system for investigations of deviations, atypical events, complaints, OOS results, and failures. Your CAPA should include but not be limited to improvements in investigation competencies, root cause analysis, documentation, written procedures, and quality unit oversight.”
    • The firm could not provide complete analytical data for several attributes of the drug product. Rather they simply reported calculated results that were on the CoA. They are to provide the information in FDA’s ‘long version’ of the Data Integrity Remediation boilerplate.


  • Montana Compounding Pharmacy (Missoula, MT) received a warning letter on May 9th 2018 based on the outcome of an inspection ending September 20th 2016 (no, not a typo). The letter focuses on GMP deficiencies in the manufacturing of non-sterile products.

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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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