Home / Import refusals / AEK-4326438-8/11/1

FDA Import Refusal AEK-4326438-8/11/1 — Apitoria Pharma Private Limited

Apitoria Pharma Private Limited — FEI 3004021253

The FDA refused shipment AEK-4326438-8/11/1 from Apitoria Pharma Private Limited (India) on March 16, 2018. The refused product falls under Drugs and Biologics — TAMSULOSIN HCL (REGULATOR). Cited charge: 16 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 16, 2018
Country
India
Product Category
Drugs and Biologics
Product Code
65PDZ03 TAMSULOSIN HCL (REGULATOR)
Charges
16

Recent inspections

  • 1283662 (VAI Fri Aug 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149904 (OAI Thu Aug 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080606 (OAI Sat Feb 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053166 (NAI Fri Apr 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992361 (VAI Tue Oct 25 2016 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)
  • 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)
  • 185-0057937-2/1/1 (Tue Jun 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources