Company
United StatesCynosure, Llc, Westford, MA – FDA Inspections
Inspection records and compliance data for Cynosure, Llc in Westford, Massachusetts. 10 FDA inspections on record, 2 Form 483s, last inspected December 12, 2025.
Company Profile
This profile covers Cynosure, Llc based in Westford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 4
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected September 15, 2011. Last inspected December 12, 2025.
Most cited issue areas
- Investigator(s) not qualified1 inspection
- Other sponsor records required by FDA inadequate1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 12, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1295506 |
| December 14, 2018 | Not classified | Medical Devices & Rad Health | 1093281 |
| July 27, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1060207 |
| December 8, 2017 | Not classified | Medical Devices & Rad Health | 1051787 |
| March 13, 2017 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1003091 |
| November 21, 2014 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 904967 |
| April 28, 2014 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 876385 |
| April 25, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 778400 |
| February 17, 2012 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 768754 |
| September 15, 2011 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 745654 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cynosure, Llc
FEI Number
1000120578
Address
5 Carlisle Rd, Westford, Massachusetts 01886, United States
Country
United States
ID: df2fbcd7-9503-465d-a074-adff2a91daa5