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Warning Letter

Case 701671 — FEI 3007490529

Facility

Recent inspections

  • 1249416 (OAI Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074310 (VAI Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969055 (VAI Tue Apr 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882533 (NAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 786162 (NAI Thu May 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Aspen SA Sterile Operations (Pty) Ltd.
Date
February 24, 2025
Fiscal Year
2025
Product Type
Drugs
Center
CDER
Location
Port Elizabeth (South Africa)