Accelerated Analytical Laboratories Inc.September 27, 2021

FDA 483 - Accelerated Analytical Laboratories Inc. - September 27, 2021

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Record Details

Accelerated Analytical Laboratories Inc. in Milwaukee, WI, a contract laboratory, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in laboratory controls, specifically regarding the establishment and suitability of microbiological test methods for drug products. Additionally, the firm failed to conduct a written investigation into an out-of-specification result during a method suitability study.

Company: Accelerated Analytical Laboratories Inc.
Inspection Date: September 27, 2021
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East VI
Person: Norman K. Starks

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ID · 4c4a6fc1-5b5e-49fb-8923-a87c8a35b614