FDA 483 - PETNET Solutions, Inc. - June 20, 2025

An FDA inspection of PET NET Solutions Inc., a PET Drug Manufacturer in Culver City, CA, revealed significant deficiencies in equipment cleaning, contamination control, and production processes. Observations included inadequate documentation of cleaning activities, failure to prevent contamination from various sources, and insufficient production and process controls to ensure drug quality. These issues indicate a lack of robust quality systems that could impact the identity, strength, quality, and purity of PET drugs.