FDA 483 - Innovatical Laboratories LLC - January 16, 2026

Innovatical Laboratories Llc, a control testing laboratory in Montclair, CA, was cited for significant deficiencies across its laboratory and quality systems. The inspection revealed severe data integrity issues, including a lack of raw data review, inadequate audit trails, and uncontrolled electronic systems with frequent software errors. Additionally, the firm failed to maintain proper written procedures, ensure adequate GMP training for personnel, and provide sufficient supervision, particularly concerning the Laboratory Manager's absence and restricted system access.