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483
•Teva Pharmaceuticals USA, Inc•September 29, 2023

Teva Pharmaceuticals USA, Inc – FDA 483, Sep 29, 2023

Record Details

Teva Pharmaceuticals USA, Inc. in Parsippany, NJ, was cited for failing to maintain adequate drug distribution and dispensing records related to its approved REMS Implementation System. Specifically, the firm did not collect dispensing records from certified inpatient pharmacies. This lapse prevented the company from ensuring restricted distribution of its drug products.

Company
Teva Pharmaceuticals USA, Inc
Inspection date
September 29, 2023
Product type
drugs
Office
New Jersey District Office
People
  • Mayar M. Mussa
  • Ashley J. Burns
  • Michael Serrano (investigator)
  • Joann M (Director)
  • Milton J. De Jesus Tavarez
View Company Profile

ID · 5190aa5a-da5d-437b-a8cf-9dce3852e6be

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