FDA 483 - Optimal Solution Labs LLC - April 17, 2026

Optimal Solution Labs LLC, a contract manufacturer of OTC drugs and cosmetics in Valencia, CA, was cited for significant deficiencies in its quality control, material testing, and in-process control procedures. The inspection revealed failures to ensure material suitability, validate supplier Certificates of Analysis, verify component identity, and adequately monitor batch uniformity during manufacturing. These issues indicate a lack of robust quality systems for drug product manufacturing.