FDA 483 - Bausch Health US., LLC. - June 16, 2021

Bausch Health Companies, Inc. in Bridgewater, NJ, was inspected regarding its corporate office operations. The inspection revealed a significant issue with the firm's failure to maintain adequate drug distribution and dispensing records for SILIQ, specifically concerning its approved REMS Implementation System. This lapse resulted in the inability to ensure SILIQ was only distributed to certified pharmacies.