FDA 483 - Precision Optics Corporation, Inc. - September 11, 2025

Precision Optics Corporation, Inc. in Gardner, MA, received a Form FDA-483 with six observations following an inspection of their medical device facility. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning control of nonconforming product, corrective and preventive actions, supplier controls, device history records, complaint handling, and product identification for their ophthalmic laser endoscopes. These issues indicate a lack of established and followed procedures across several critical manufacturing and quality processes.