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

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.