FDA 483 - BioAnalysis, LLC - January 26, 2024

BioAnalysis, LLC, a contract testing laboratory in Philadelphia, PA, received a Form 483 with two observations. The inspection revealed deficiencies in the firm's quality control unit regarding the review and approval of changes to written procedures, as well as a failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. These issues indicate a lack of robust quality system controls over laboratory operations and investigations.