Precision Optics Corporation, Inc. – FDA 483, Mar 31, 2023

An FDA inspection of Precision Optics Corporation, Inc. in Gardner, MA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for handling complaints, managing rework of nonconforming products, and implementing corrective and preventive actions. These issues indicate a lack of robust control over critical quality processes.