Home / Import refusals / AEK-1123503-1/12/1D

FDA Import Refusal AEK-1123503-1/12/1D — Chattem Inc

Chattem Inc — FEI 2222017

The FDA refused shipment AEK-1123503-1/12/1D from Chattem Inc (United States) on June 30, 2022. The refused product falls under Devices — IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE. Cited charges: 118,237,3280,84 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 30, 2022
Country
United States
Product Category
Devices
Product Code
79LMH IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
Charges
118,237,3280,84

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-5436912-8/10001/1 (Tue Jun 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 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-0093850-4/11/35 (Wed Mar 22 2023 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)

FDA data resources