FDA Inspection
PneumRx, Inc.PneumRx, Inc. – FDA Inspection, Aug 23, 2011
Record Details
This FDA Inspection record concerns PneumRx, Inc., with an inspection on August 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- PneumRx, Inc.
- Inspection Date
- August 23, 2011
- Product Type
- Devices
View Company Profile
ID · 6d18f30e-b781-4bef-8e4c-8fd7fdb0119d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741996
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PneumRx, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2017 | Not classified | San Francisco District Office | |
| September 20, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for PneumRx, Inc.
- FDA Inspection 1028627 - 2017-09-22
- FDA Inspection 942581 - 2015-09-20
- FDA Inspection 901292 - 2014-10-16
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