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Mylan Laboratories Limited — FDA Facility Profile

FEI 3010453141

Mylan Laboratories Limited is an FDA-registered facility (FEI 3010453141) located in Madhya Pradesh 454775, IN. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Madhya Pradesh 454775 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 1095599 (NAI Fri May 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 960871 (VAI Fri Feb 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870220 (VAI Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • AEK-9307357-3/10003/1 (Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-9867116-1/11/1 (Tue Apr 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • B8P-0304813-3/11/1 (Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5060456-2/11/1 (Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3591151-2/11/1 (Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4886626-1/11/1 (Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-2620661-3/11/1 (Tue Jan 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-9936481-4/11/1 (Fri Feb 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3953857-4/21/1 (Wed Sep 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources