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FDA Import Refusal 185-0057013-2/1/1 — Apitoria Pharma Private Limited

Apitoria Pharma Private Limited — FEI 3004611182

The FDA refused shipment 185-0057013-2/1/1 from Apitoria Pharma Private Limited (India) on December 19, 2012. The refused product falls under Drugs and Biologics — BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 19, 2012
Country
India
Product Category
Drugs and Biologics
Product Code
62OCZ15 BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II)
Charges
75

Recent inspections

  • 1178447 (VAI Tue Aug 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1082414 (OAI Sat Feb 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005706 (NAI Tue Feb 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 927750 (NAI Thu Apr 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 790022 (VAI Fri Jun 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-2659829-0/11/1 (Thu Jan 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0444538-1/11/1 (Thu Feb 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4326438-8/11/1 (Fri Mar 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 201-3007858-7/11/1 (Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 201-9643026-7/1/1 (Wed Oct 28 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources