# FDA 483 - PETNET Solutions Inc - April 21, 2023

Source: https://www.keypedia.com/records/483/petnet-solutions-inc/ce18ed77-c210-4931-94a4-31a0ea9b16f1

> FDA 483 for PETNET Solutions Inc on April 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions Inc
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of PETNET Solutions Inc's Pet Drug Corporate Headquarters in Knoxville, TN, revealed significant deficiencies in laboratory controls and manufacturing processes. Observations included unsuitable analytical methods, a lack of established specifications for PET drug products, and inadequate process controls for in-process materials. These issues indicate potential risks to product quality and purity.

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/petnet-solutions-inc/e4b295dd-c782-487d-9407-3fcfe4e9f9f1

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6