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FDA Warning Letter — Exela Pharma Sciences LLC

Case 708301 — FEI 3008563008

The FDA took a Warning Letter action against Exela Pharma Sciences LLC on July 2, 2025 (Lenoir, NC). The action was issued by CDER and concerns drugs products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Exela Pharma Sciences LLC
Date
July 2, 2025
Fiscal Year
2025
Product Type
Drugs
Center
CDER
Location
Lenoir, NC (United States)

Facility

Recent inspections

  • 1256957 (OAI Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096634 (VAI Thu Jul 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081405 (NAI Wed Dec 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067755 (NAI Tue Sep 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026858 (VAI Thu Sep 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

FDA data resources