Accugen Laboratories, Inc.April 22, 2022

FDA 483 - Accugen Laboratories, Inc. - April 22, 2022

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Record Details

An FDA inspection of Accugen Laboratories, Inc. in Addison, IL, a contract laboratory, revealed significant deficiencies in laboratory controls and record-keeping. The firm failed to demonstrate the suitability of its USP71-Sterility Test method and lacked a proper quality agreement with its sponsor. Additionally, laboratory records were found to be incomplete, missing analyst initials, dates, and clear time notations.

Company: Accugen Laboratories, Inc.
Inspection Date: April 22, 2022
Product Type: Drugs
Office: Chicago District Office
People: Muna Algharibeh (Investigator)
Norman K. Starks

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ID · c5bf4b00-bc67-45a7-9144-edb489163b2f