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FDA Import Refusal AEK-1560940-4/3/1 — MEDGEL PRIVATE LIMITED

MEDGEL PRIVATE LIMITED — FEI 3010165392

The FDA refused shipment AEK-1560940-4/3/1 from MEDGEL PRIVATE LIMITED (India) on January 5, 2016. The refused product falls under Drugs and Biologics — DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD). Cited charges: 118,16 This firm has 5 or more other import refusals on record.

Refusal Details

Date
January 5, 2016
Country
India
Product Category
Drugs and Biologics
Product Code
62UAE11 DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD)
Charges
118,16

Recent inspections

  • 1261975 (VAI Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1196836 (OAI Fri Jan 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1077046 (VAI Fri Jan 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986369 (VAI Fri May 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • BPQ-1136665-0/51/1 (Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BPQ-1136665-0/11/1 (Fri Nov 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BPQ-1133654-7/51/1 (Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BPQ-1133987-1/31/1 (Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1560940-4/1/1 (Tue Jan 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources