# FDA 483 - PETNET Solutions, Inc - September 08, 2023

Source: https://www.keypedia.com/records/483/petnet-solutions-inc/507b2d84-cffc-48fc-83a8-85edcf9c943d

> FDA 483 for PETNET Solutions, Inc on September 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc
- Inspection Date: 2023-09-08
- Product Type: drugs
- Office Name: Denver District Office
- Summary: PETNET Solutions, Inc. in Phoenix, AZ, a PET drug product manufacturer, was cited for three observations during an FDA inspection. The firm's facilities were found inadequate for preventing contamination, leading to sterility test failures and consistent microbial recovery. Additionally, investigations into nonconforming PET drug batches were insufficient, and procedures for equipment cleaning and facility maintenance were not properly implemented, resulting in various deficiencies.

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)
- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

Company: https://www.keypedia.com/companies/petnet-solutions-inc/8997b099-2de9-4f32-ba06-1ec18ec16556

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face