FDA 483 - Precision Nuclear of Virginia - March 25, 2022

Precision Nuclear of Virginia, a PET Drug Manufacturer in Roanoke, VA, was cited for three observations during an FDA inspection. The firm's facilities were found inadequate for preventing contamination due to inconsistent environmental monitoring. Additionally, the company failed to follow written quality assurance procedures, leading to discrepancies in batch records and incomplete GMP documentation, and lacked adequate production and process controls, specifically regarding supplier verification.