Week of October 8th 2018 | FDA Sent These Warning Letters to Device Companies

FDA posted 6 warning letters this week including:

  • 1 to a device manufacturer
  • 1 for seafood HACCP
  • 1 for food preparation
  • 3 for tobacco


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  • Becton Dickinson Medical Systems (Franklin Kales, NJ) received a warning letter on September 14th 2018 based on the outcome of an inspection that lasted from May 16th 2018 through August 1st 2018 (yes).
    • When the FDA issues a warning letter 6 weeks after the inspection it signals their concern about the safety of the products in question.
    • It is worth noting that the warning letter was addressed to the Chairman and CEO, rather than the site head at the Franklin Wisconsin site that was the subject of the inspection.
    • The site manufactures pre-filled Heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringes — both regulated as devices by FDA. Deficiencies include but are not limited to:
      • Failure to adequately control environmental conditions. At issue is microbial contamination of water used to prepare solutions to clean and disinfect surfaces of the Class 10,000 clean rooms and Class 100 laminar flow hoods. The firm does not routinely monitor incoming municipal water.
      • The firm failed to establish adequate procedures to prevent contamination of equipment.  
      • Staff were not following adequate clean room practices particularly when performing operations in the Class 100 laminar flow hoods. The second deficiency in the warning letter provides a long list of the microbial species in the clean room areas.
      • The firm did not identify valid statistical techniques for controlling and verifying process capability and product characteristics. The sterility testing sample plan or alert/action for EM is not based on adequate plans.
      • Monitoring of EM and differential pressure is inadequate.


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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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