PETNET Solutions, Inc.January 27, 2020

FDA 483 - PETNET Solutions, Inc. - January 27, 2020

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Record Details

An FDA inspection of PETNET Solutions, Inc., a PET Drug Manufacturer in Culver City, CA, revealed significant deficiencies across various quality system elements. The firm failed to establish adequate procedures for environmental monitoring, manufacturing process controls, vendor qualification, and analytical testing. Additionally, the inspection found issues with the firm's handling of nonconforming products and the completeness of root cause investigations.

Company: PETNET Solutions, Inc.
Inspection Date: January 27, 2020
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Carrie A. Hughes
Uttaniti Limchumroon
Krishna Ghosh

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ID · 509da5ef-c1f1-4519-9035-24188a5079b9