Week of November 25th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

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Week of November 25th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA posted 9 warning letters last week, one of which was issued to a clinical investigator.

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CLINICAL INVESTIGATOR:

  • Corona Doctors Medical Clinics, Inc (Corona, CA) received a warning letter on November 16, 2018 based on the outcome of an inspection ending June 27, 2018.  Deficiencies include but are not limited to the following:
    • Clinical study drug was administered to six subjects after the study was placed on clinical hold and this hold was repeatedly communicated to the site, both verbally and in writing. In one case the study drug was administered just a few hours after the FDA notified the firm in a teleconference that they were on clinical hold.
    • Two subjects received study drug prior to the IND going into effect.  

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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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