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FDA Import Refusal 322-2557301-7/21/1 — Hikma Pharmaceuticals USA INC.

Hikma Pharmaceuticals USA INC. — FEI 1510690

The FDA refused shipment 322-2557301-7/21/1 from Hikma Pharmaceuticals USA INC. (United States) on January 12, 2022. The refused product falls under Drugs and Biologics — LINAGLIPTIN (ANTI-DIABETIC). Cited charges: 118,3280,472 This firm has 5 or more other import refusals on record.

Refusal Details

Date
January 12, 2022
Country
United States
Product Category
Drugs and Biologics
Product Code
61PCA66 LINAGLIPTIN (ANTI-DIABETIC)
Charges
118,3280,472

Recent inspections

  • 1303412 (NAI Thu Apr 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1238509 (NAI Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1243797 (NAI Tue Jul 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1182363 (NAI Thu Sep 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113855 (NAI Fri Nov 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-7156999-2/11/1 (Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9SN-0007009-6/101/1 (Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9SN-0007009-6/11/1 (Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8JB-0093850-4/11/52 (Wed Mar 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8JB-0093850-4/11/26 (Wed Mar 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources