FDA Inspection
Pulmonx, Corp.Pulmonx, Corp. – FDA Inspection, Nov 8, 2016
Record Details
This FDA Inspection record concerns Pulmonx, Corp., with an inspection on November 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ec2f0407-d0d0-4182-90c2-49a70d591c9d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 993003
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pulmonx, Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2026 | Not classified | San Francisco District Office | |
| February 21, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Pulmonx, Corp.
- FDA Inspection 1316830 - 2026-07-02
- FDA Inspection 862529 - 2014-02-21
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