Company
United StatesPulsar Vascular Inc., Los Gatos, CA – FDA Inspections
Inspection records and compliance data for Pulsar Vascular Inc. in Los Gatos, California. 3 FDA inspections on record, 1 Form 483, last inspected March 01, 2017.
Company Profile
This profile covers Pulsar Vascular Inc. based in Los Gatos, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected November 13, 2015. Last inspected March 1, 2017.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Sponsor records of investigator agreements inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 1, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003264 |
| September 15, 2016 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 991330 |
| November 13, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 949188 |
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
Pulsar Vascular Inc.
FEI Number
3008680601
Address
130 Knowles Dr Ste E, Los Gatos, California 95032, United States
Country
United States
ID: 00ff4ec5-fe9c-411c-bec0-7e55b86f5d24