Home / Import refusals / AEK-7594168-0/10002/1

FDA Import Refusal AEK-7594168-0/10002/1 — Pfizer Manufacturing Deutschland GmbH

Pfizer Manufacturing Deutschland GmbH — FEI 3002807097

The FDA refused shipment AEK-7594168-0/10002/1 from Pfizer Manufacturing Deutschland GmbH (Germany) on September 19, 2025. The refused product falls under Drugs and Biologics — AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II). Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 19, 2025
Country
Germany
Product Category
Drugs and Biologics
Product Code
62OCA14 AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
Charges
118

Recent inspections

  • 1222873 (VAI Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085284 (VAI Fri Mar 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1021100 (NAI Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 966853 (NAI Fri Mar 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 875506 (VAI Thu Apr 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-8297178-8/10002/1 (Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9397964-7/10002/1 (Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7896703-9/10003/1 (Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7713852-5/10002/1 (Wed Oct 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • F23-9339962-1/40002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources