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

Source: https://www.keypedia.com/records/483/precision-nuclear-of-virginia/2409cf16-498e-45f4-bc1c-f5a141e7d5a5

> FDA 483 for Precision Nuclear of Virginia on March 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precision Nuclear of Virginia
- Inspection Date: 2022-03-25
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: 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.

## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/precision-nuclear-of-virginia/072341dd-051b-4749-8d94-814374d2bacf

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64