# FDA 483 - PETNET SOLUTIONS, INC. - February 15, 2023

Source: https://www.globalkeysolutions.net/records/483/petnet-solutions-inc/9f91e80a-af94-477f-b41b-ebf6cd437576

> FDA 483 for PETNET SOLUTIONS, INC. on February 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET SOLUTIONS, INC.
- Inspection Date: 2023-02-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of PETNET SOLUTIONS, INC. in Broken Arrow, OK, a PET drug manufacturer, revealed significant deficiencies in equipment construction and maintenance, cleaning procedures, and batch production records. The firm failed to ensure equipment surfaces were non-reactive, implement adequate cleaning validation, and properly document major equipment used in batch production. These issues indicate a lack of control over critical manufacturing processes for PET drugs.

## Related Officers

- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.globalkeysolutions.net/companies/petnet-solutions-inc/b853869f-3c2e-4ab8-927f-4b6f81afd83f

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab