Home / Import refusals / AEK-7515529-9/10002/1

FDA Import Refusal AEK-7515529-9/10002/1 — Merck & Co. Inc

Merck & Co. Inc — FEI 2211017

The FDA refused shipment AEK-7515529-9/10002/1 from Merck & Co. Inc (United States) on August 13, 2025. The refused product falls under Drugs and Biologics — SOMATROPIN. Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 13, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
58HDL05 SOMATROPIN
Charges
118

Recent inspections

  • 1305632 (NAI Fri Mar 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1283890 (NAI Thu Dec 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1262774 (NAI Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1264192 (NAI Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1158317 (NAI Thu Nov 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-9254299-0/10001/1 (Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7462726-4/30001/1 (Tue Aug 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-6705454-8/91/1 (Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5766294-0/11/1 (Sat Nov 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-7987432-0/11/1 (Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources