FDA 483 - PETNET Solutions, Inc. - February 27, 2026

An FDA inspection of PETNET Solutions, Inc. in Jacksonville, FL, identified critical deficiencies in the firm's PET drug manufacturing operations. Observations included inadequate production oversight with unauthorized product withdrawals, a lack of thorough investigations for out-of-specification results, and incomplete laboratory records. Additionally, the firm failed to properly document major equipment in batch records and ensure equipment suitability, indicating significant gaps in quality control and compliance with manufacturing standards.