FDA 483 - PETNET Solutions Inc. - November 04, 2025

PETNET Solutions Inc. in Woburn, MA, a PET drug manufacturer, was cited for significant deficiencies across its quality system, including inadequate investigations into unknown peaks and equipment excursions, failure to follow and justify deviations from production procedures, and facility issues impacting contamination control. The inspection also found problems with equipment qualification and adherence to quality assurance procedures, indicating a systemic lack of control over critical manufacturing processes and environmental conditions.