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FDA Import Refusal 427-7323858-1/7/2 — Sato Pharmaceutical Co., Ltd.

Sato Pharmaceutical Co., Ltd. — FEI 3004055563

The FDA refused shipment 427-7323858-1/7/2 from Sato Pharmaceutical Co., Ltd. (Japan) on November 22, 2011. The refused product falls under Drugs and Biologics — CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 22, 2011
Country
Japan
Product Category
Drugs and Biologics
Product Code
61XBL08 CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC)
Charges
118,75

Recent inspections

  • 1292356 (OAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111704 (NAI Thu Nov 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107699 (VAI Fri Oct 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064716 (VAI Tue Jul 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961508 (OAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-9603810-5/11/1 (Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-5600815-6/1/1 (Tue Mar 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 224-4713484-6/1/1 (Wed Aug 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 224-2480967-5/9/1 (Wed Dec 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 224-2480967-5/1/1 (Wed Dec 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources