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

PETNET Solutions, Inc. in Jacksonville, FL, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in production oversight, process controls, laboratory record-keeping, batch record completeness, and equipment procedures for PET drug manufacturing. These issues indicate a lack of robust quality systems to ensure drug safety, quality, and purity.