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FDA Import Refusal 9ES-0094279-5/10002/1 — INKE S.A.

INKE S.A. — FEI 3003663245

The FDA refused shipment 9ES-0094279-5/10002/1 from INKE S.A. (Spain) on August 8, 2025. The refused product falls under Drugs and Biologics — GLYCOPYRROLATE (ANTI-CHOLINERGIC). Cited charges: 118,75 This firm has 3 other import refusals on record.

Refusal Details

Date
August 8, 2025
Country
Spain
Product Category
Drugs and Biologics
Product Code
61KDY22 GLYCOPYRROLATE (ANTI-CHOLINERGIC)
Charges
118,75

Recent inspections

  • 1313264 (VAI Wed Mar 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111970 (VAI Wed Apr 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988740 (NAI Fri Apr 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821831 (VAI Fri Jan 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 601782 (VAI Sat Jul 25 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 9ES-0094279-5/20002/1 (Fri Aug 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6247734-2/11/1 (Tue May 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1004893-7/1/1 (Wed Oct 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

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