# FDA 483 - PETNET Solutions, Inc. - January 27, 2020

Source: https://www.keypedia.com/records/483/petnet-solutions-inc/509da5ef-c1f1-4519-9035-24188a5079b9

> FDA 483 for PETNET Solutions, Inc. on January 27, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc.
- Inspection Date: 2020-01-27
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of PETNET Solutions, Inc., a PET Drug Manufacturer in Culver City, CA, revealed significant deficiencies across various quality system elements. The firm failed to establish adequate procedures for environmental monitoring, manufacturing process controls, vendor qualification, and analytical testing. Additionally, the inspection found issues with the firm's handling of nonconforming products and the completeness of root cause investigations.

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- [483 - 2025-06-20](https://www.keypedia.com/records/483/petnet-solutions-inc/e7c60851-0b79-48f5-b3db-d7f6a440bd8d)

## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)
- [issuing_officer](https://www.keypedia.com/people/krishnakali-ghosh/3787eba9-13b2-4f4d-8a59-57e76b8c9706)
- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

Company: https://www.keypedia.com/companies/petnet-solutions-inc/4e6f1f92-939d-4ae6-93b3-bf67932e71d7

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6