Precision Nuclear of Virginia, LLCOctober 17, 2025

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

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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.

Company: Precision Nuclear of Virginia, LLC
Inspection Date: October 17, 2025
Product Type: Drugs
Office: Baltimore District Office
People: David A. Oluwo (Pharmacy Intern/Certified Pharmacy Technician)
Kara J. Wright

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ID · ba59c14b-7941-4376-968b-3fb270c0b68d