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

Source: https://www.globalkeysolutions.net/records/483/precision-nuclear-of-virginia-llc/ba59c14b-7941-4376-968b-3fb270c0b68d

> FDA 483 for Precision Nuclear of Virginia, LLC on October 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precision Nuclear of Virginia, LLC
- Inspection Date: 2025-10-17
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: 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.

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [Kara J. Wright](https://www.globalkeysolutions.net/people/kara-j-wright/d12b6a4f-9710-4811-b1b2-5ff5f9342155)

Company: https://www.globalkeysolutions.net/companies/precision-nuclear-of-virginia-llc/2e47b9e0-b7b2-46c4-a5c3-d77e3331b114

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa