Home / Import refusals / AEK-8020380-3/21/1

FDA Import Refusal AEK-8020380-3/21/1 — Cipla Limited

Cipla Limited — FEI 3008581988

The FDA refused shipment AEK-8020380-3/21/1 from Cipla Limited (India) on January 8, 2025. The refused product falls under Drugs and Biologics — DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
January 8, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
61XCY18 DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC)
Charges
75

Recent inspections

  • 1198343 (OAI Fri Feb 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1094880 (NAI Fri May 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1048005 (VAI Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940719 (VAI Fri Aug 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821114 (VAI Fri Mar 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-3441591-9/20002/4 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-1905741-3/20002/4 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-1905741-3/20002/5 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-4688178-4/10002/1 (Tue Jun 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-9797841-4/20002/1 (Tue Jun 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources