Week of May 6th 2018 | FDA Sent These Warning Letters to Pharma Companies

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Week of May 6th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 12 new warning letters this week. Among the ones we cover one to a finished pharmaceutical firm.

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  • Goran Pharma Private Limited (Gujarat, India) received a warning letter dated April 24th 2018 based on the outcome of an inspection ending November 15th 2017. The firm was placed on import alert 66-40 on March 5th 2018. FDA also suggests they contract with a qualified consultant(s) to assist them in coming into GMP compliance. The deficiencies include but are not limited to:
    • Components are received on the basis of the supplier’s CoA but are not tested. The item in question identified in the warning letter is glycerin which the firm failed to test for the presence of diethylene glycol or ethylene glycol. The firm is to respond to the following and provide:
      • “a detailed description of how you will ensure that components (e.g., ingredients) used in the manufacture of your drug products will be withheld from use until the lot has been tested in accordance with the current United States Pharmacopoeia (USP) and released for use by the quality unit;
      • an improved procedure that describes how you qualify your suppliers’ COA both initially and on an ongoing basis. Explain whether you intend to test each lot of incoming components for all attributes instead of relying on the suppliers’ COA. Alternatively, if you intend to rely on the supplier’s COA, provide specifics on how you will verify each supplier’s test results at regular intervals and include a commitment to test at minimum every incoming component lot for USP identity requirements.
      • a detailed risk assessment for drug products that contain glycerin and are within expiry in the U.S. market. As part of your risk assessment, immediately test retained samples of all lots for DEG and EG, and take appropriate market action if the testing yields any aberrant results.
      • a comprehensive, independent review of your laboratory practices, methods, equipment, and analyst competencies. Based on this review, provide a detailed corrective action and preventive action (CAPA) plan to remediate your laboratory systems.”
    • The firm did not review all batch records and test results before releasing product. Product was shipped prior to completion of microbiological testing. As part of the response to the warning letter the firm is to “…submit updated procedures and corrective actions to ensure that your quality unit will review complete records prior to making a finished product batch disposition decision. Additionally, provide a CAPA that establishes an adequate quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.”
    • The firm lacked an adequate air handling system including controlling and monitoring of temperature/humidity in the warehouse and manufacturing areas. FDA asks them to provide:
      • “a detailed action plan for ensuring adequate control and monitoring of temperature, humidity, and air cleanliness in your facility
      • a comprehensive, independent assessment of your facilities and equipment. This assessment should include a full evaluation of the suitability of the design, control, and maintenance of your equipment and facilities. Based on this review, provide a detailed CAPA plan.”
    • Deficiency #3 appears to address deficiencies in a water system design and maintenance. The firm has apparently installed a new system, but FDA asks that they provide the following:
      • “a detailed plan for validation of the new (b)(4) system
      • procedures for routine monitoring of the (b)(4) system as well as system control and maintenance
      • scientific justification for the frequency, (b)(4), and duration that you will use to sanitize the (b)(4) system
      • a risk assessment for products manufactured prior to installation and validation of the new (b)(4) system
      • your rationale for relying on past data to characterize the (b)(4) system’s state of control, given the microbiology laboratory deficiencies noted during the inspection.”

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About the Author

Barbara W. Unger

Barbara W. Unger 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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