FDA 483 - Allied Analytical Laboratory Services Inc - March 02, 2022

Allied Analytical Laboratory Services Inc, a contract testing lab in Millington, TN, received a Form 483 with two observations. The inspection revealed issues with apparatus not meeting established specifications, specifically an out-of-tolerance analytical balance. Additionally, the firm failed to maintain written records of investigations into unexplained discrepancies, such as aborted HPLC sample sets, and lacked a procedure for such investigations.