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Warning Letter

Case 620588 — FEI 3003068822

Facility

Recent inspections

  • 1219486 (OAI Mon Sep 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1151570 (OAI Tue Sep 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116566 (OAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1078170 (VAI Fri Feb 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065575 (VAI Fri Sep 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
ULTRAtab Laboratories, Inc.
Date
March 14, 2022
Fiscal Year
2022
Product Type
Drugs
Center
CDER
Location
Highland, NY (United States)