FDA Inspection 926541 — Nova Pneuma, Inc.
The FDA completed an inspection of Nova Pneuma, Inc. on May 21, 2015 in Fremont, CA. 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) (NAI)
- End Date
- May 21, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |