# FDA 483 - PETNET Solutions, Inc. - October 17, 2022

Source: https://www.keypedia.com/records/483/petnet-solutions-inc/fc7c7f5d-986c-466b-aace-0fa59542fca7

> FDA 483 for PETNET Solutions, Inc. on October 17, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc.
- Inspection Date: 2022-10-17
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of PETNet Solutions, Inc. in Cincinnati, OH, a PET drug manufacturer, revealed significant deficiencies in their manufacturing processes. Observations included inadequate equipment cleaning procedures, improper handling of sterile components leading to potential contamination, and a lack of established action limits for radiochemical yield in master production records. These issues indicate a need for improved quality control and adherence to good manufacturing practices.

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Courtney E. Hillier](https://www.keypedia.com/people/courtney-e-hillier/4bb6ba54-896a-4296-a4ea-81d8801fdc2f)
- [Torrey M. Ward](https://www.keypedia.com/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

Company: https://www.keypedia.com/companies/petnet-solutions-inc/a03ce27e-ade2-4adb-85d3-b91d774273ca

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22