FDA 483 - Applied Consumer Services Inc. - February 21, 2020

Applied Consumer Services Inc. in Hialeah Gardens, FL, a contract test laboratory, received a Form 483 for significant deficiencies in their quality control system. The firm failed to thoroughly review unexplained discrepancies and out-of-specification (OOS) results, lacking scientific justification and proper documentation in multiple investigations. Additionally, laboratory personnel did not adhere to written analytical methods, with unrecorded and unjustified deviations from established procedures.