Company
United StatesPneumRx, Inc., Santa Clara, CA – FDA Inspections
Inspection records and compliance data for PneumRx, Inc. in Santa Clara, California. 4 FDA inspections on record, last inspected September 22, 2017.
Company Profile
This profile covers PneumRx, Inc. based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 23, 2011. Last inspected September 22, 2017.
Most cited issue areas
- Sponsors" general responsibilities2 inspections
- Sponsor correspondence records inadequate1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 22, 2017 | Not classified | Medical Devices & Rad Health | 1028627 |
| September 20, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 942581 |
| October 16, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 901292 |
| August 23, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 741996 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
PneumRx, Inc.
FEI Number
3005823838
Address
4255 Burton Dr, Santa Clara, California 95054, United States
Country
United States
ID: 462c77c1-f107-4728-8edf-e72f2321cd5d