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FDA Import Refusal 112-8849362-4/1/1 — Bayer Healthcare Pharmaceuticals Inc.

Bayer Healthcare Pharmaceuticals Inc. — FEI 2243252

The FDA refused shipment 112-8849362-4/1/1 from Bayer Healthcare Pharmaceuticals Inc. (United States) on May 30, 2012. The refused product falls under Drugs and Biologics — DROSPIRENONE. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 30, 2012
Country
United States
Product Category
Drugs and Biologics
Product Code
65JDA39 DROSPIRENONE
Charges
75

Recent inspections

  • 1286004 (NAI Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1277153 (NAI Fri Aug 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1251837 (NAI Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1196111 (NAI Wed Feb 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153395 (NAI Wed Sep 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-6429231-1/11/1 (Mon Jan 03 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0256520-8/11/1 (Thu Jan 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-0475966-0/11/4 (Fri Jun 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6264407-2/11/1 (Mon Sep 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-0147820-6/11/1 (Mon Aug 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources