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FDA Import Refusal 9UA-0287614-4/61/1A — Unichem Laboratories Limited

Unichem Laboratories Limited — FEI 3005497507

The FDA refused shipment 9UA-0287614-4/61/1A from Unichem Laboratories Limited (India) on March 27, 2023. The refused product falls under Drugs and Biologics — SILDENAFIL CITRATE (REGULATOR). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 27, 2023
Country
India
Product Category
Drugs and Biologics
Product Code
65PCY02 SILDENAFIL CITRATE (REGULATOR)
Charges
118,75

Recent inspections

  • 1243288 (VAI Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1159456 (VAI Sun Jan 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102049 (VAI Wed Jul 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922923 (VAI Fri Apr 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777002 (VAI Fri Apr 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • M85-1804246-9/21/1E (Mon Oct 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4314583-7/11/1 (Wed Dec 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5558237-0/11/1 (Tue Jan 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9589770-6/71/1 (Mon Jan 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-2406183-8/11/2 (Thu Oct 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources