FDA 483 - Anesthesia Associates Inc - March 14, 2019

Anesthesia Associates Inc, a medical device manufacturer in San Marcos, CA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate process control procedures, specifically undocumented assembly instructions and training records for a Class II life-sustaining device. The firm also lacked maintained written Medical Device Reporting (MDR) procedures and failed to document the evaluation of multiple suppliers for critical components.