FDA Warning Letters Week of 10/27/2019: Sterility and Spores

A slow week for drug and device warning letters as FDA continues their enforcement focus on e-cigarette suppliers.  Enforcement this week includes a lone GMP warning letter to a PET drug manufacturer.

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DRUGS | PETNET Solution Inc. 

PETNET Solution Inc. received a warning letter on October 17, 2019 based on the outcome of an inspection ending April 5, 2019.  FDA notes this is part of large corporation with facilities throughout the United States and encourages them to assess their procedures and practices at all sites.

Deficiencies include but are not limited to:

• Facilities are not suitable for manufacture of aseptically filled sterile drug products.  This includes facility maintenance and environmental monitoring that showed trends of spore-forming organisms.
• Action levels and testing procedures for environmental monitoring are not adequate or appropriate.  The sterility test procedure lacks information on disinfecting and material flow.