Home / Import refusals / ES3-2528351-4/51/1

FDA Import Refusal ES3-2528351-4/51/1 — Solta Medical Inc

Solta Medical Inc — FEI 3003079710

The FDA refused shipment ES3-2528351-4/51/1 from Solta Medical Inc (United States) on August 31, 2018. The refused product falls under Devices — POWERED SURGICAL INSTRUMENTS FOR IMPROVEMENT IN THE APPEARANCE OF CELLULITE. Cited charges: 118,476 This firm has 4 other import refusals on record.

Refusal Details

Date
August 31, 2018
Country
United States
Product Category
Devices
Product Code
79OUP POWERED SURGICAL INSTRUMENTS FOR IMPROVEMENT IN THE APPEARANCE OF CELLULITE
Charges
118,476

Recent inspections

  • 882308 (VAI Tue Jun 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873862 (NAI Thu Apr 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798415 (OAI Fri Aug 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 755598 (NAI Fri Dec 02 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-2310202-0/1/1 (Fri Aug 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • DO7-7810269-2/1/1 (Fri Nov 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • ANQ-2030199-0/1/1 (Tue Aug 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 9TV-0000378-0/1/1 (Wed Feb 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources