Company
United StatesSyneron, Inc., Irvine, CA – FDA Inspections
Inspection records and compliance data for Syneron, Inc. in Irvine, California. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected August 15, 2018.
Company Profile
This profile covers Syneron, Inc. based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 6, 2010. Last inspected August 15, 2018.
Most cited issue areas
- Lack of Written MDR Procedures2 inspections
- Documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 15, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1062605 |
| September 12, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 895132 |
| July 5, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 733570 |
| August 6, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 675278 |
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
Syneron, Inc.
FEI Number
3004772125
Address
3 Goodyear Ste A, Irvine, California 92618, United States
Country
United States
ID: 29dd4332-40fd-4266-83a9-82aaa92eb4f3