FDA 483 - Innovatical Laboratories LLC - January 16, 2026

Innovatical Laboratories Llc in Montclair, CA, a control testing laboratory, was cited for significant deficiencies across its laboratory and quality systems during an FDA inspection from January 13-16, 2026. The inspection revealed severe issues with data integrity, including lack of raw data review, inadequate SOPs for chromatography systems, uncontrolled electronic records, and disabled software message centers leading to data deletion. Additionally, the firm lacked proper microbiological laboratory controls and failed to ensure adequate CGMP training and supervision for its personnel.