# FDA 483 - Medipharm Laboratories, Inc. - February 23, 2024

Source: https://www.keypedia.com/records/483/medipharm-laboratories-inc/2a373049-47be-4bf2-91d8-36291f7ea71d

> FDA 483 for Medipharm Laboratories, Inc. on February 23, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medipharm Laboratories, Inc.
- Inspection Date: 2024-02-23
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Medipharm Laboratories, Inc. in Miami, FL, a contract testing laboratory, revealed significant deficiencies in their quality system and employee training. The firm failed to maintain written Quality Agreements with all clients and an outsource contractor, and did not follow its own annual review procedure. Additionally, employees in the Quality Unit and Laboratory operations lacked documented training in cGMP, cGLP, or cGDP.

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

Company: https://www.keypedia.com/companies/medipharm-laboratories-inc/a8bd08bd-3c1c-429f-bb8e-87a487445ec4

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6