FDA 483 - Anesthesia Associates Inc - December 18, 2023

An FDA inspection of Anesthesia Associates Inc. in San Marcos, CA, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm lacked adequate procedures for purchasing, corrective and preventive actions, device history records, complaint handling, acceptance activities, device master records, and design history files. These observations indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.