FDA Inspection 993003 — Pulmonx, Corp.
The FDA completed an inspection of Pulmonx, Corp. on Nov 8, 2016 in Redwood City, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 8, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Redwood City, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |