FDA Inspection 1113755 — EKF Diagnostics, Inc. dba EFK Life Sciences
The FDA completed an inspection of EKF Diagnostics, Inc. dba EFK Life Sciences on December 13, 2019 in Elkhart, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 13, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elkhart, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |