BioAnalysis, LLCJanuary 26, 2024

FDA 483 - BioAnalysis, LLC - January 26, 2024

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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.

Company: BioAnalysis, LLC
Inspection Date: January 26, 2024
Product Type: Drugs
Office: Philadelphia District Office
People: Yoriann M. Cabrera Bartolomei
Evan Tong
Junho Pak (Investigator)

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ID · 3b57b2ff-6f73-4293-8ca0-e7bd25d71743