Week of August 5th 2018 | FDA Sent These Warning Letters to Pharma Companies

This week the FDA published 4 warning letters (3 to seafood companies and 1 to an API manufacturer – Les Produits Chimiques B.G.R. Inc).  We cover the latter below.


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  • Les Produits Chimiques B.G.R. Inc (Montreal, Canada) received a warning letter on July 24th 2018 based on the outcome of an inspection ending September 27th 2017. The firm manufactures APIs. The firm is encouraged to read ICHQ7 for guidance on manufacturing of APIs in compliance with GMPs. FDA also recommends that the firm employ qualified consultants to assist them in coming into GMP compliance. The warning letter only identifies 2 deficiencies:
    • The firm released and distributed multiple lots of APIs without completing required release testing for identity even though the COA reported that the product met all required specifications. The firm indicated that the identity test “PASSED” in the COA but had no data to support this analysis. In their response, the firm provided retrospective testing on all distributed lots manufactured since 2015. FDA asks the firm to provide the following in their response to the warning letter:
      • A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Include a detailed description of the scope and root causes of your data integrity lapses.
      • A current risk assessment of the potential effects of the data integrity deviations on the quality of your API. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity.
      • A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm, including laboratory data and manufacturing records. 
    • The Quality unit did not exercise their responsibility as shown by their failure to perform critical functions including: failure to ensure that records included complete data derived from all tests; failure to ensure that stability samples were stored under controlled temperature and humidity; failure to ensure that buildings were in an adequate state of cleanliness because investigators observed insects and spider webs on plastic-wrapped containers used for packaging of APIs; and failure to ensure that cleaning validation records documented rinse times in the validation study. They are asked to provide the following to FDA:
      • Update your documentation procedure to clarify the information that is to be recorded in laboratory notebooks;
      • Purchase a stability chamber and improve your stability program;
      • Clean and transfer packaging materials to a location in the warehouse where you prevent entry of pests, and train personnel on packaging material inspection requirements;
      • Repeat your cleaning validation with documented rinse times, and update corresponding cleaning procedures and checklists.
    • The FDA also stated:
      • Your response did not provide sufficient detail or evidence that your proposed corrective actions and preventive actions (CAPA) will bring your operations into compliance with CGMP.
      • In response to this letter, provide the CAPA plans and procedures you have implemented to ensure that the roles and responsibilities of the quality unit are clearly defined and established. This should include but not be limited to assuring your quality assurance unit has the appropriate authority and resources needed to carry out its responsibilities.
      • Also provide:
        • A revised documentation procedure that specifies the detailed information that must be recorded in laboratory notebooks;
        • Evidence to demonstrate that you have purchased and qualified a stability chamber, as well as your updated stability protocol;
        • Your procedures for appropriate storage and inspection of raw materials;
        • The report that summarizes your new cleaning validation studies; and
        • Your revised cleaning procedures and checklists.


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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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