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FDA Import Refusal 300-4616816-7/11/1 — Opto-Pharm Pte Ltd.

Opto-Pharm Pte Ltd. — FEI 3005320466

The FDA refused shipment 300-4616816-7/11/1 from Opto-Pharm Pte Ltd. (Singapore) on July 20, 2019. The refused product falls under Drugs and Biologics — WATER, PURIFIED (EYEWASH). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 20, 2019
Country
Singapore
Product Category
Drugs and Biologics
Product Code
65FAK06 WATER, PURIFIED (EYEWASH)
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

  • 231-4924371-6/10002/1 (Mon Dec 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 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)
  • 300-4617372-0/11/1 (Fri Jul 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources