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Warning Letter

Case 542310 — FEI 3003849479

Facility

Recent inspections

  • 1295650 (NAI Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1254447 (NAI Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1219353 (NAI Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1176357 (NAI Mon Jul 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1148356 (NAI Fri Jul 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Aphena Pharma Solutions - Tennessee LLC
Date
December 5, 2017
Fiscal Year
2018
Product Type
Drugs
Center
CDER
Location
Cookeville, TN (United States)