Home / Import refusals / 799-8679784-8/11/1

FDA Import Refusal 799-8679784-8/11/1 — Starkey Laboratories Inc

Starkey Laboratories Inc — FEI 2125608

The FDA refused shipment 799-8679784-8/11/1 from Starkey Laboratories Inc (United States) on February 8, 2017. The refused product falls under Devices — HEARING-AID, MASTER. Cited charges: 118,341,508 This firm has 4 other import refusals on record.

Refusal Details

Date
February 8, 2017
Country
United States
Product Category
Devices
Product Code
77KHL HEARING-AID, MASTER
Charges
118,341,508

Recent inspections

  • 1264301 (NAI Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1071531 (VAI Tue Nov 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898175 (NAI Wed Oct 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 759329 (NAI Thu Dec 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 595817 (NAI Tue Jul 07 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 231-1336903-1/28/1 (Thu Mar 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-4781367-3/1/1 (Wed Jan 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-7314611-8/1/1 (Mon Jul 11 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-7314611-8/1/2 (Mon Jul 11 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources