Company
United StatesLumasense Technologies, Inc., Santa Clara, CA – FDA Inspections
Inspection records and compliance data for Lumasense Technologies, Inc. in Santa Clara, California. 2 FDA inspections on record, last inspected August 28, 2013.
Company Profile
This profile covers Lumasense Technologies, Inc. based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected April 16, 2010. Last inspected August 28, 2013.
Most cited issue areas
- Quality audits - Lack of or inadequate procedures2 inspections
- CAPA verification/validation of corrective/preventive action1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 28, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 847589 |
| April 16, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 660358 |
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
Lumasense Technologies, Inc.
FEI Number
2936522
Address
3301 Leonard Ct, Santa Clara, California 95054, United States
Country
United States
ID: f18c3e5b-f9f1-4eaa-943e-b4720f3ab105