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American Regent, Inc. — FDA Facility Profile

FEI 2410375

American Regent, Inc. is an FDA-registered facility (FEI 2410375) located in Shirley, NY, US. RegDataLab tracks 10 or more FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Shirley, NY (US)
Registration Expires
N/A
Operations
Source
inspections

Recent inspections

  • 1236810 (VAI Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118512 (NAI Fri Nov 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047853 (VAI Wed Apr 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963173 (VAI Sun Feb 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963315 (VAI Fri Feb 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 901719 (VAI Wed Oct 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 767250 (VAI Thu Mar 29 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 713642 (OAI Tue Mar 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 695919 (VAI Fri Oct 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 695077 (VAI Wed Oct 06 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • 8JB-0093850-4/11/34 (Wed Mar 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-0579037-7/1/1 (Wed Dec 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 739-6181375-2/1/1 (Thu Aug 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-7119290-3/1/1 (Tue May 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • UPS-1126704-2/1/1C (Tue May 27 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)
  • 112-2467270-9/1/1 (Wed Feb 04 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources