# FDA 483 - PETNET Solutions, Inc. - December 04, 2025

Source: https://www.globalkeysolutions.net/records/483/petnet-solutions-inc/a561dc08-ac68-4cf3-af1d-f456633d8c7d

> FDA 483 for PETNET Solutions, Inc. on December 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc.
- Inspection Date: 2025-12-04
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: An FDA inspection of PETNET Solutions, Inc. in Sacramento, CA, revealed significant deficiencies in their manufacturing processes for PET drug products. The firm failed to investigate numerous repeat system suitability failures for gas chromatography equipment, raising concerns about the validity of analytical test results. Additionally, the inspection identified inadequate cleaning and sanitization procedures, including issues with operator gowning, documentation of disinfectant contact times, and controls for cleaning agents.

## Related Officers

- [Gloria E. Andia](https://www.globalkeysolutions.net/people/gloria-e-andia/50f145fd-5e25-4a02-bc59-364bcb02b9c8)
- [Investigator](https://www.globalkeysolutions.net/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)

Company: https://www.globalkeysolutions.net/companies/petnet-solutions-inc/beb8542c-50d5-4d93-a208-9979733b14df

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df