# FDA 483 - PETNET Solutions, Inc. - September 16, 2019

Source: https://www.globalkeysolutions.net/records/483/petnet-solutions-inc/a258a06b-0890-4712-be98-b209f682a91e

> FDA 483 for PETNET Solutions, Inc. on September 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc.
- Inspection Date: 2019-09-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: During an inspection, PETNET Solutions, Inc. in Hayward, CA, was cited for significant deficiencies in laboratory test records and computer system controls related to the manufacturing of Axumin (fluciclovine F 18). The firm's system for determining chemical purity lacked unique user access, had disabled data audit trails, and allowed operators to delete raw data. These issues indicate serious concerns regarding data integrity and compliance with good manufacturing practices.

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## Related Officers

- [Nancy E. Booker](https://www.globalkeysolutions.net/people/nancy-e-booker/547f5f8b-c7f0-4f41-81f2-bc51da12e8ad)
- [Senior Lead Reviewer and Intercenter Consult Team Leader](https://www.globalkeysolutions.net/people/nayan-j-patel/0436f014-4b1b-4e54-8df0-576d51a354b2)
- [Utanilil Limchuneuron](https://www.globalkeysolutions.net/people/utanilil-limchuneuron/e109c487-14f4-49b7-a041-b1468dde8d4d)

Company: https://www.globalkeysolutions.net/companies/petnet-solutions-inc/ac7f9df8-900b-4663-8a91-ec0e10c5137c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b