Ace Products & Consulting LLC – FDA 483, Apr 4, 2024
An FDA inspection of Ace Products & Consulting LLC, a contract testing lab in Ravenna, OH, revealed significant deficiencies in quality control and data integrity. The firm failed to properly investigate out-of-specification results and retested samples without scientific justification. Additionally, the inspection found inadequate controls over computer systems, including a lack of user permissions, audit trails, and individual logins for GC-MS software, alongside missing or unfollowed written procedures for investigations and data review.
ID · d7cda1d9-9393-4d9e-bc7a-071aade930b9
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