Home / Import refusals / 1FX-5436912-8/10001/1

FDA Import Refusal 1FX-5436912-8/10001/1 — Chattem Inc

Chattem Inc — FEI 2222017

The FDA refused shipment 1FX-5436912-8/10001/1 from Chattem Inc (United States) on June 23, 2026. The refused product falls under Drugs and Biologics — INSULIN LISPRO PROTAMINE (ANTI-DIABETIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 23, 2026
Country
United States
Product Category
Drugs and Biologics
Product Code
61PCY58 INSULIN LISPRO PROTAMINE (ANTI-DIABETIC)
Charges
75

Recent inspections

  • 1235539 (NAI Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230103 (NAI Wed Feb 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1156765 (NAI Fri Oct 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074575 (NAI Tue Oct 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987709 (VAI Wed Aug 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-5436912-8/20001/1 (Tue Jun 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-3709518-5/10003/1 (Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8JB-0093850-4/11/28 (Wed Mar 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8JB-0093850-4/11/35 (Wed Mar 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1123503-1/12/1D (Thu Jun 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources