FDA 483 - MPS Anzon LLC - August 13, 2021

An FDA inspection of MPS Anzon LLC in Arcadia, CA, from August 10-13, 2021, revealed deficiencies in the firm's quality system. The primary observation noted inadequate documentation of corrective and preventive action activities. Specifically, the firm failed to conduct a retrospective review after discovering past-due calibration dates for critical in-process and final inspection tools, including some found to be out of tolerance.