483
Bausch Health US., LLC.FDA 483 - Bausch Health US., LLC. - June 16, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 11f7d9b5-bc0d-4053-b37a-85303478cd64