FDA 483 - Silliker Laboratories Group, Inc - June 30, 2025

Silliker, Inc. in Cypress, CA, a control testing laboratory, was issued a Form 483 with three observations following an FDA inspection. The inspection revealed significant deficiencies in the quality control unit's adherence to procedures, inadequate calibration and qualification of laboratory equipment, and a lack of documented verification for drug product sample testing methods. These issues indicate a concerning lack of control over critical laboratory processes.