FDA 483 - ACTA Laboratories, Inc. - January 19, 2018

An FDA inspection of ACTA Laboratories, Inc. in Foothill Ranch, CA, revealed significant deficiencies in laboratory controls and data integrity. The firm failed to verify testing methods, lacked appropriate controls over computerized systems, and did not maintain written records of investigations into unexplained discrepancies. These issues indicate a lack of robust quality systems for pharmaceutical testing and data management.