Home / Import refusals / 1FX-2356917-0/10002/3

FDA Import Refusal 1FX-2356917-0/10002/3 — Intas Pharmaceuticals Limited

Intas Pharmaceuticals Limited — FEI 3003157498

The FDA refused shipment 1FX-2356917-0/10002/3 from Intas Pharmaceuticals Limited (India) on April 17, 2026. The refused product falls under Drugs and Biologics — ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC). Cited charges: 118,27,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 17, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
61JDA08 ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
Charges
118,27,75

Recent inspections

  • 1245599 (NAI Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098380 (VAI Fri Aug 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074349 (NAI Fri Dec 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056170 (VAI Fri Jun 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978469 (VAI Fri Jun 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-5380728-4/10002/2 (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-2344992-8/20002/2 (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-2344992-8/20002/1 (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-4495920-2/20002/4 (Wed May 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-4495920-2/20002/1 (Wed May 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources