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Warning Letter

Case 710997 — FEI 1000526900

Facility

Recent inspections

  • 1276408 (NAI Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1250450 (OAI Tue Apr 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068298 (VAI Wed Oct 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030174 (VAI Mon Oct 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915250 (VAI Mon Feb 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
DermaRite Industries, LLC
Date
October 27, 2025
Fiscal Year
2026
Product Type
Drugs
Center
CDER
Location
North Bergen, NJ (United States)