483
Grace Analytical Lab IncFDA 483 - Grace Analytical Lab Inc - September 29, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Office
- Chicago District Office
- Person
Open in Dashboard
ID · 2010f89f-ad36-4c71-ad82-faf99648d509