FDA 483 - ACTA Laboratories, Inc. - February 13, 2023

ACTA Laboratories, Inc. in Foothill Ranch, CA, was inspected and received a Form 483 with three observations. The inspection revealed significant issues with the quality control unit's procedures, including failures in stability program investigations, sample processing, and lack of written procedures for critical activities. Additionally, deficiencies were noted in ongoing GMP training for employees and adherence to written sanitation procedures, with evidence of pest activity.