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FDA Import Refusal J37-0009050-2/121/1G — Przedsiebiorstwo Farmaceutyczne Jelfa SA

Przedsiebiorstwo Farmaceutyczne Jelfa SA — FEI 3004680543

The FDA refused shipment J37-0009050-2/121/1G from Przedsiebiorstwo Farmaceutyczne Jelfa SA (Poland) on May 24, 2017. The refused product falls under Drugs and Biologics — FLUOCINOLONE ACETONIDE (GLUCOCORTICOID). Cited charges: 118,16,3280,472 This firm has 2 other import refusals on record.

Refusal Details

Date
May 24, 2017
Country
Poland
Product Category
Drugs and Biologics
Product Code
64LCJ27 FLUOCINOLONE ACETONIDE (GLUCOCORTICOID)
Charges
118,16,3280,472

Recent inspections

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  • 1050200 (NAI Tue Mar 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991418 (VAI Thu Sep 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885404 (NAI Mon Jun 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 794037 (VAI Tue May 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-6904863-5/11/6 (Tue Feb 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)
  • 799-8284934-9/31/7 (Wed Nov 04 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)

FDA data resources