# FDA 483 - Med-Pharmex, Inc. - December 18, 2023

Source: https://www.keypedia.com/records/483/med-pharmex-inc/071fc123-2cfb-4baf-b633-db22723311ce

> FDA 483 for Med-Pharmex, Inc. on December 18, 2023. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Med-Pharmex, Inc.
- Inspection Date: 2023-12-18
- Product Type: veterinary
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Med-Pharmex, Inc. in Pomona, CA, was inspected and cited for significant deficiencies in its manufacturing processes and quality control. Observations included inadequate production and process controls, unvalidated test methods, undocumented production procedures, and improper handling of drug product components, leading to product quality issues and numerous customer complaints, including adverse drug events. The inspection revealed repeat observations, indicating persistent issues.

## Related Documents

- [483 - 2019-05-17](https://www.keypedia.com/records/483/med-pharmex-inc/1655f7ea-1d31-43a0-8942-b534cd060165)
- [483 - 2021-09-14](https://www.keypedia.com/records/483/med-pharmex-inc/aaac6039-6a2c-4319-934d-c7172f85bd63)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/med-pharmex-inc/fc3eae98-cbb3-4470-89f2-ef8f616f0a87

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