FDA Inspection 755677 — Non-Invasive Monitoring Systems, Inc.
The FDA completed an inspection of Non-Invasive Monitoring Systems, Inc. on October 28, 2011 in Miami, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 28, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |