FDA 483 - Grace Analytical Lab Inc - September 29, 2021

Grace Analytical Lab Inc, a control testing lab in Berkeley, IL, was cited for significant deficiencies across its quality control unit, laboratory records, computer system controls, and personnel. The inspection revealed issues including data integrity concerns with backdated entries, lack of qualified QA personnel, unvalidated systems, and insufficient employee training in GMP. These findings indicate a systemic failure to adhere to good manufacturing practices.