Company
United StatesKentec Medical, Inc, Irvine, CA – FDA Inspections
Inspection records and compliance data for Kentec Medical, Inc in Irvine, California. 5 FDA inspections on record, 1 Form 483, last inspected July 30, 2018.
Company Profile
This profile covers Kentec Medical, Inc based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected December 16, 2009. Last inspected July 30, 2018.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 30, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1060879 |
| May 11, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 928285 |
| September 24, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 897383 |
| October 19, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 803967 |
| December 16, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 636354 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Kentec Medical, Inc
FEI Number
2080225
Address
17871 Fitch, Irvine, California 92614, United States
Country
United States
ID: 84a3c6bd-182a-4acd-bf51-a7482ed87bd7