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Warning Letter

Case 489914 — FEI 3010680515

Facility

Recent inspections

  • 1265449 (VAI Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167934 (OAI Tue Apr 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097950 (OAI Tue Jul 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023411 (OAI Tue Aug 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928445 (OAI Fri May 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

Action Details

Facility
US Specialty Formulations LLC
Date
September 30, 2016
Fiscal Year
2016
Product Type
Drugs
Center
CDER
Location
Allentown, PA (United States)