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FDA Import Refusal 231-4924371-6/10002/1 — Opto-Pharm Pte Ltd.

Opto-Pharm Pte Ltd. — FEI 3005320466

The FDA refused shipment 231-4924371-6/10002/1 from Opto-Pharm Pte Ltd. (Singapore) on December 29, 2025. The refused product falls under Drugs and Biologics — PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.. Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 29, 2025
Country
Singapore
Product Category
Drugs and Biologics
Product Code
55YP99 PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C.
Charges
27

Recent inspections

  • 1178651 (OAI Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1078347 (OAI Fri Jan 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 970156 (OAI Tue Mar 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854767 (VAI Mon Jun 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-2285203-5/10002/1 (Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7911493-9/11/1 (Tue Jul 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • WX5-0230184-8/61/6 (Thu Jan 09 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 300-4616816-7/11/1 (Sat Jul 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 300-4617372-0/11/1 (Fri Jul 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources