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Warning Letter

Case 578557 — FEI 3006900385

Facility

Recent inspections

  • 1272585 (OAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1181903 (OAI Fri Oct 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1141073 (OAI Mon May 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073636 (NAI Thu Nov 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025749 (VAI Tue Sep 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
ALK-Abello, Inc.
Date
June 24, 2019
Fiscal Year
2019
Product Type
Drugs
Center
CDER
Location
Plainville, CT (United States)