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FDA Import Refusal 336-6404264-8/1/1 — Hikma Farmaceutica, (Portugal) S.A.

Hikma Farmaceutica, (Portugal) S.A. — FEI 3002807173

The FDA refused shipment 336-6404264-8/1/1 from Hikma Farmaceutica, (Portugal) S.A. (Portugal) on April 5, 2011. The refused product falls under Drugs and Biologics — SODIUM FERRIC GLUCONATE COMPLEX IN SUCRO (ANTI-ANEMIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 5, 2011
Country
Portugal
Product Category
Drugs and Biologics
Product Code
61CCP07 SODIUM FERRIC GLUCONATE COMPLEX IN SUCRO (ANTI-ANEMIC)
Charges
75

Recent inspections

  • 1203129 (VAI Fri Apr 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1254066 (VAI Fri Feb 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1125050 (VAI Fri Mar 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050480 (NAI Thu Mar 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 970483 (VAI Tue Apr 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • UPS-6124775-5/1/1 (Wed May 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 279-9843729-0/1/1 (Wed May 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 279-9843729-0/1/2 (Wed May 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 279-9843729-0/1/3 (Wed May 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • UPS-3899659-3/1/1 (Wed Mar 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources