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FDA Import Refusal K64-1074863-1/131/1 — Okamoto Industries, Inc.

Okamoto Industries, Inc. — FEI 3006122980

The FDA refused shipment K64-1074863-1/131/1 from Okamoto Industries, Inc. (Japan) on November 2, 2021. The refused product falls under Devices — CONDOM. Cited charges: 3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 2, 2021
Country
Japan
Product Category
Devices
Product Code
85HIS CONDOM
Charges
3280,341

Recent inspections

  • 937073 (OAI Thu Jul 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-7359160-6/11/1 (Fri May 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-9581784-8/11/1 (Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-0946336-6/11/1 (Thu Nov 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-0767302-6/11/1 (Wed Mar 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-7641654-3/11/1 (Fri Sep 04 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources