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FDA Import Refusal KC2-1012196-0/1/1 — Innolatex Sdn. Bhd.

Innolatex Sdn. Bhd. — FEI 3003117682

The FDA refused shipment KC2-1012196-0/1/1 from Innolatex Sdn. Bhd. (Malaysia) on March 12, 2012. The refused product falls under Devices — FEMALE CONDOM, REPEATED USE. Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 12, 2012
Country
Malaysia
Product Category
Devices
Product Code
85OBU FEMALE CONDOM, REPEATED USE
Charges
118,508

Recent inspections

  • 1215638 (VAI Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009128 (NAI Thu Mar 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752824 (NAI Thu Nov 03 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709156 (OAI Thu Jan 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • KC2-1012196-0/1/2 (Mon Mar 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • KC2-1012196-0/1/4 (Mon Mar 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • KC2-1012196-0/1/3 (Mon Mar 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-4399239-8/2/1 (Wed Nov 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 315-7352076-9/1/1 (Thu Jul 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources