FDA 483 - BPI Labs - June 12, 2019

An FDA inspection of BFT Labs, Inc. in Evanston, WY, a medical device manufacturer, from June 10-12, 2019, revealed extensive deficiencies across its quality system. The firm lacked established procedures for critical processes such as validation, medical device reporting, supplier management, CAPA, design change, document control, quality audits, and management review. Additionally, issues were identified with device history records, equipment maintenance, environmental controls, and personnel training, indicating a systemic failure to maintain compliance for its personal lubricant products.