# FDA 483 - PETNET Solutions, Inc. - May 21, 2021

Source: https://www.globalkeysolutions.net/records/483/petnet-solutions-inc/de45e604-fe49-43ff-9239-4d2293ef1200

> FDA 483 for PETNET Solutions, Inc. on May 21, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc.
- Inspection Date: 2021-05-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: This FDA Form 483 was issued to PETNET Solutions, Inc. in Jacksonville, FL, a Positron Emission Tomography Drug Manufacturer. The inspection revealed significant deficiencies in quality control, including a lack of procedures for final product release based on laboratory data review and issues with electronic batch record audit trails. Additionally, the firm failed to properly handle and store components, leading to concerns about contamination control in aseptic processing areas.

## Related Officers

- [Nakesha J Jackson](https://www.globalkeysolutions.net/people/nakesha-j-jackson/7ff47efe-9786-4296-b8c3-6fb5a25b805e)
- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

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

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