# FDA 483 - PETNET Solutions, Inc. - February 27, 2026

Source: https://www.keypedia.com/records/483/petnet-solutions-inc/67a1182d-264b-4502-8dd5-bab1b5d115af

> FDA 483 for PETNET Solutions, Inc. on February 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc.
- Inspection Date: 2026-02-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of PETNET Solutions, Inc. in Jacksonville, FL, identified critical deficiencies in the firm's PET drug manufacturing operations. Observations included inadequate production oversight with unauthorized product withdrawals, a lack of thorough investigations for out-of-specification results, and incomplete laboratory records. Additionally, the firm failed to properly document major equipment in batch records and ensure equipment suitability, indicating significant gaps in quality control and compliance with manufacturing standards.

## Related Documents

- [483 - 2021-05-21](https://www.keypedia.com/records/483/petnet-solutions-inc/de45e604-fe49-43ff-9239-4d2293ef1200)
- [483 - 2026-02-27](https://www.keypedia.com/records/483/petnet-solutions-inc/f7c3897d-4baa-479c-a669-83096a88c803)

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/petnet-solutions-inc/d94675b1-d9be-4fb3-8f61-c5c0aed94514

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