FDA 483 - Banyan USA LLC - September 12, 2023

Banyan USA LLC, a manufacturer of surgical masks in Hauppauge, NY, was inspected by the FDA from September 5-12, 2023. The inspection revealed significant deficiencies across its quality system, including a lack of documented process validation, incoming product acceptance, supplier evaluation, and equipment maintenance schedules. Additionally, critical quality system procedures for MDR, complaint handling, document control, quality audits, and management review were either absent or not followed, indicating a broad failure to establish and maintain adequate controls for medical device manufacturing.