Company
United StatesCynosure, Inc., Hicksville, NY – FDA Inspections
Inspection records and compliance data for Cynosure, Inc. in Hicksville, New York. 4 FDA inspections on record, 1 Form 483, last inspected March 10, 2017.
Company Profile
This profile covers Cynosure, Inc. based in Hicksville, New York, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 26, 2010. Last inspected March 10, 2017.
Most cited issue areas
- Acceptable supplier records, inadequate records2 inspections
- Design plans- updated1 inspection
- Documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 10, 2017 | Not classified | Medical Devices & Rad Health | 1008712 |
| August 7, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 890615 |
| May 11, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 781457 |
| May 26, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 663451 |
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
Cynosure, Inc.
FEI Number
2428235
Address
400 Karin Ln, Hicksville, New York 11801, United States
Country
United States
ID: adf2c4a8-e326-4552-8bf1-7f95e324b9b3