FDA 483 - Banyan USA LLC - September 12, 2023

An FDA inspection of Banyan USA LLC, a medical device manufacturer, was conducted from September 5-12, 2023. The inspection revealed nine significant deviations from established quality system regulations. Key issues included a lack of documented process validation for surgical mask manufacturing and insufficient documentation for the acceptance or rejection of incoming product materials. The company also failed to document the evaluation of its suppliers and had not established proper maintenance schedules for its manufacturing equipment.

Furthermore, critical procedural deficiencies were observed, such as the absence of written Medical Device Reporting (MDR) procedures, a lack of established procedures for receiving and evaluating customer complaints, and no documented procedures for overall document control within their quality system. The inspection also noted that internal quality audits had not been performed, and management had not conducted periodic reviews of the quality system's suitability and effectiveness. Banyan USA LLC committed to addressing all identified observations, necessitating the development, implementation, and robust documentation of corrective actions to ensure compliance with regulatory standards.