Company
United StatesTeraRecon, Inc., Foster City, CA – FDA Inspections
Inspection records and compliance data for TeraRecon, Inc. in Foster City, California. 3 FDA inspections on record, last inspected June 29, 2015.
Company Profile
This profile covers TeraRecon, Inc. based in Foster City, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 11, 2010. Last inspected June 29, 2015.
Most cited issue areas
- Design verification - Lack of or inadequate procedures1 inspection
- Documentation1 inspection
- Document review, approval by designated individual1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 29, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 932214 |
| October 23, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 803564 |
| June 11, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 665677 |
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
TeraRecon, Inc.
FEI Number
3003243710
Address
4000 E 3rd Ave Ste 200, Foster City, California 94404, United States
Country
United States
ID: 954290fa-f431-4540-a49b-40bb409f3fa5