FDA 483 - Ace Products & Consulting LLC - April 04, 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.