Applied Consumer Services Inc. – FDA 483, Feb 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.
ID · dd3d8795-e4ea-4186-a652-b146e09c4c2b
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