483
Bausch Health US., LLC.FDA 483 - Bausch Health US., LLC. - November 07, 2024
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During an inspection, Bausch Health US., LLC. was cited for failing to maintain adequate drug distribution and dispensing records for its approved REMS Implementation System. Specifically, the firm did not ensure that SILIQ was only distributed to certified pharmacies, as required by its REMS program. This indicates a significant lapse in oversight regarding restricted drug distribution.
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ID · 3e4f42e1-1b96-426a-8138-68ddf864f234