Company
United StatesClarity Medical Systems Inc, Pleasanton, CA – FDA Inspections
Inspection records and compliance data for Clarity Medical Systems Inc in Pleasanton, California. 4 FDA inspections on record, last inspected March 17, 2017.
Company Profile
This profile covers Clarity Medical Systems Inc based in Pleasanton, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected June 30, 2011. Last inspected March 17, 2017.
Most cited issue areas
- Design verification - output does not meet input requirement1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 17, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1004666 |
| May 15, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 831573 |
| July 20, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 794931 |
| June 30, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 730094 |
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
Clarity Medical Systems Inc
FEI Number
3004014430
Address
5775 W Las Positas Blvd Ste 200, Pleasanton, California 94588, United States
Country
United States
ID: cf43e179-b5a3-40e7-b97e-13d9db359901