483
BioAnalysis, LLCBioAnalysis, LLC – FDA 483, Jan 26, 2024
Record Details
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.
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ID · 3b57b2ff-6f73-4293-8ca0-e7bd25d71743
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