Company
United StatesAmerican Imex, Irvine, CA – FDA Inspections
Inspection records and compliance data for American Imex in Irvine, California. 3 FDA inspections on record, last inspected January 20, 2016.
Company Profile
This profile covers American Imex based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 16, 2011. Last inspected January 20, 2016.
Most cited issue areas
- Investigation of device failures2 inspections
- Lack of or inadequate procedures - Acceptance activities2 inspections
- Lack of Written MDR Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 20, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 958092 |
| May 18, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 927130 |
| December 16, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 758825 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
American Imex
FEI Number
2083018
Address
16520 Aston, Irvine, California 92606, United States
Country
United States
ID: b509b173-db68-45c8-a536-d5f67ea4bd83