Company
United StatesElectromedical Products International, Inc., Mineral Wells, TX – FDA Inspections
Inspection records and compliance data for Electromedical Products International, Inc. in Mineral Wells, Texas. 4 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected February 02, 2018.
Company Profile
This profile covers Electromedical Products International, Inc. based in Mineral Wells, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected December 18, 2009. Last inspected February 2, 2018.
Most cited issue areas
- Approval, inadequate purchasing data1 inspection
- DMR - not or inadequately maintained1 inspection
- DMR QA procedures and specifications1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1039669 |
| January 29, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 863799 |
| February 1, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 816802 |
| December 18, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 636051 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Electromedical Products International, Inc.
FEI Number
2020648
Address
2201 Garrett Morris Pkwy, Mineral Wells, Texas 76067, United States
Country
United States
ID: 92c6e4f2-4e3c-4c0e-8c26-d059cf43145b