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

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.