483
Medipharm Laboratories, Inc.Medipharm Laboratories, Inc. – FDA 483, Feb 23, 2024
Record Details
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.
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ID · 2a373049-47be-4bf2-91d8-36291f7ea71d
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