Week of December 2nd 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

The FDA posted 9 warning letters this week, one to a drug product manufacturer, one to a device manufacturer and one to a manufacturer of human tissues/cellular products.  We cover these three below.

 

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HUMAN CELLS / TISSUES:

  • Human Biologics of Texas / Globus Medical received a warning letter on October 30, 2018, based on the outcome of an inspection ending April 9, 2018.  Deficiencies include but are not limited to:
    • The firm failed to investigate repeated product sterility failures.
    • The firm did not validate the manufacturing process to effectively prevent the introduction, transmission or spread of communicable diseases.  The product was commercialized without being made by a validated process. The warning letter lists a variety of examples of why they reached this conclusion.

DEVICES:

  • Mibo Medical Group received a warning letter on November 20, 2018, based on the outcome of an inspection ending May 10, 2018. Deficiencies include but are not limited to:
    • Procedures for design inputs and outputs have not been established.  
    • Procedures for design verification have not been established.
    • Failure to establish and maintain a design history file
    • Failure to perform risk analyses to identify possible hazards associated with the design of the device.
    • Failure to establish CAPA procedures, and during the inspection the firm stated they were unaware they were supposed to have such procedures.
    • Two critical raw materials were purchased from vendors that were not on the approved supplier’s list.
    • Testing of the final device isn’t supported by protocols or acceptance criteria to ensure it meets appropriate acceptance criteria
    • The firm did not have a procedure governing complaint handling and MDR procedures.
    • The firm has not conducted any internal audits
    • The firm does not have a Quality Policy.

DRUGS:

  • Barox Co., Ltd, (South Korea)  received a warning letter on November 28, 2018, based on the outcome of an inspection ending May 18, 2018.  FDA suggested that the firm employ qualified consultants to help them come into GMP compliance.  FDA also placed the firm on import alert on November 8, 2018. The firm manufactures OTC products.  Deficiencies include but are not limited to:
    • The firm does not have a procedure(s) describing the roles and responsibilities of the quality unit. Further, all employees, even those in the Quality Unit, lack knowledge of GMP requirements.
    • There are no procedures for relabeling operations.  The firm relabels OTC product made by a contract manufacturer.
    • The firm does not have procedures for warehousing and storage of drug products including those in quarantine storage before the release of product.

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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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