Company
United StatesEKF Diagnostics, Inc. dba EFK Life Sciences, Elkhart, IN – FDA Inspections
Inspection records and compliance data for EKF Diagnostics, Inc. dba EFK Life Sciences in Elkhart, Indiana. 4 FDA inspections on record, last inspected November 09, 2022.
Company Profile
This profile covers EKF Diagnostics, Inc. dba EFK Life Sciences based in Elkhart, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected December 16, 2013. Last inspected November 9, 2022.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1190460 |
| December 13, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1113755 |
| March 15, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1004471 |
| December 16, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 859098 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
EKF Diagnostics, Inc. dba EFK Life Sciences
FEI Number
1832837
Address
1814 Leer Dr, Elkhart, Indiana 46514, United States
Country
United States
ID: 92731961-c3e8-4cec-bb06-e45b12bbe095