FDA Inspection 1064663 — EMIT Corporation
The FDA completed an inspection of EMIT Corporation on Sep 6, 2018 in Houston, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 6, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |