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Warning Letter

Case 496551 — FEI 3002644678

Facility

Recent inspections

  • 1269549 (VAI Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120647 (VAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119158 (NAI Tue Jan 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042332 (NAI Fri Feb 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1038658 (NAI Mon Dec 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Elite Laboratories Inc.
Date
August 25, 2016
Fiscal Year
2016
Product Type
Drugs
Center
CDER
Location
Northvale, NJ (United States)