Home / Import refusals / 112-8247534-6/1/1

FDA Import Refusal 112-8247534-6/1/1 — Mylan Pharmaceuticals Inc

Mylan Pharmaceuticals Inc — FEI 1110315

The FDA refused shipment 112-8247534-6/1/1 from Mylan Pharmaceuticals Inc (United States) on August 8, 2011. The refused product falls under Drugs and Biologics — ISOTRETINOIN (KERATOLYTIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 8, 2011
Country
United States
Product Category
Drugs and Biologics
Product Code
64XCB11 ISOTRETINOIN (KERATOLYTIC)
Charges
75

Recent inspections

  • 1311680 (NAI Tue Apr 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1219018 (NAI Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1170444 (VAI Thu May 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099590 (VAI Thu Aug 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076082 (NAI Fri Nov 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-4732872-7/11/1 (Tue Mar 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-3225077-9/11/1 (Mon May 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-2783875-2/11/1 (Mon Feb 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-2786470-9/11/1 (Tue Jan 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-1068884-6/21/1 (Fri Aug 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources