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Mylan Laboratories Limited — FDA Facility Profile

FEI 3005587313

Mylan Laboratories Limited is an FDA-registered facility (FEI 3005587313) located in Maharashtra 422113, IN. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 8 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Maharashtra 422113 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 1117137 (NAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076887 (NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050962 (VAI Thu Apr 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986244 (OAI Wed Sep 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920472 (VAI Wed Mar 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801056 (NAI Thu Aug 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 730088 (VAI Fri May 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 607779 (NAI Sat Aug 08 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • 799-2425585-4/11/1 (Tue Jan 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • B8P-0191185-2/21/1 (Fri Apr 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • B8P-0191185-2/31/1 (Fri Apr 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • B8P-0191185-2/41/1 (Fri Apr 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8771027-1/11/1 (Fri Dec 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6601264-0/11/1 (Mon Jul 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8969517-1/11/1 (Wed Feb 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6297450-2/1/1 (Tue Jul 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-7440242-2/1/1 (Fri Dec 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-7440242-2/6/1 (Fri Dec 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources