# FDA 483 - PETNET Solutions, Inc. - February 21, 2020

Source: https://www.keypedia.com/records/483/petnet-solutions-inc/8ed0c2a6-3270-422a-8f7c-be0274d9755d

> FDA 483 for PETNET Solutions, Inc. on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc.
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of PETNET Solutions, Inc. in Loma Linda, CA, revealed significant deficiencies in their PET drug manufacturing operations. Observations included inadequate production and process controls, failure to implement appropriate corrective and preventive actions for quality problems, and the use of expired components in drug production. These issues indicate a lack of control over critical manufacturing processes and quality systems.

## Related Documents

- [EIR - 2020-02-21](https://www.keypedia.com/records/eir/petnet-solutions-inc/62c5da21-48d9-4fd1-9207-7d121ba86c57)

## Related Officers

- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

Company: https://www.keypedia.com/companies/petnet-solutions-inc/2cbae8a1-124d-441c-aead-a95a860e4b1e

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