FDA 483 - Precision Nuclear of Virginia, LLC - October 17, 2025

Precision Nuclear of Virginia, LLC, a PET Drug Manufacturer in Salem, VA, received a Form 483 with two repeat observations. The inspection revealed failures in following written quality assurance procedures, including inadequate investigations into equipment malfunctions and failure to submit a Field Alert Report. Additionally, the firm lacked sufficient data to support cleaning validation for production equipment and deviated from validated cleaning procedures.