Home / Import refusals / 1FX-2842397-7/10001/1

FDA Import Refusal 1FX-2842397-7/10001/1 — American Regent, Inc.

American Regent, Inc. — FEI 3010209784

The FDA refused shipment 1FX-2842397-7/10001/1 from American Regent, Inc. (United States) on May 1, 2026. The refused product falls under Drugs and Biologics — OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 1, 2026
Country
United States
Product Category
Drugs and Biologics
Product Code
66NIY02 OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II
Charges
75

Recent inspections

  • 1300772 (VAI Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1181474 (VAI Fri Sep 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993760 (NAI Fri Oct 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 971841 (VAI Thu May 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918587 (VAI Thu Mar 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 8JB-0093850-4/11/34 (Wed Mar 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-0579037-7/1/1 (Wed Dec 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 739-6181375-2/1/1 (Thu Aug 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-7119290-3/1/1 (Tue May 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • UPS-1126704-2/1/1C (Tue May 27 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)

FDA data resources