CYNOSURE, LLC — FDA Facility Profile
CYNOSURE, LLC is an FDA-registered facility (FEI 1000120578) located in Westford, MA, US. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 12, 2025: No Action Indicated (NAI)
- Inspections on record
- 8 (5 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 3, latest Oct 7, 2022
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 12, 2025 | No Action Indicated (NAI) | No citations listed |
| Jul 27, 2018 | Voluntary Action Indicated (VAI) | Process control procedures, Lack of or inadequate procedures (21 CFR 820.70(a)) |
| Mar 13, 2017 | No Action Indicated (NAI) | No citations listed |
| Nov 21, 2014 | Voluntary Action Indicated (VAI) | Complaints (21 CFR 820.198(a)) Lack of required elements (21 CFR 1002.13) Individual Report of Malfunction (21 CFR 803.50(a)(2)) |
| Apr 28, 2014 | Voluntary Action Indicated (VAI) | Investigator(s) not qualified (21 CFR 812.43(a)) Other sponsor records required by FDA inadequate (21 CFR 812.140(b)(6)) |
| Apr 25, 2012 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Software validation for automated processes (21 CFR 820.70(i)) Report of Death or Serious Injury (21 CFR 803.50(a)(1)) |
| Feb 17, 2012 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) |
| Sep 15, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Oct 7, 2022 | Class III | F-0090-2023 | 1. Calm and Renew Serum 2. Beautiful Energy Starter Kit PN: 921-7054-120 that contains… Product does not contain SPF that is declared on the label. |
| Jan 20, 2022 | Class III | F-0807-2022 | 1. Calm and Renew Serum
2. Beautiful Energy Starter Kit PN: 921-7054-120 that contains… cosmetic inner packaging lists SPF but the product does not contain SPF |
| Oct 9, 2014 | Class II | Z-0169-2015 | Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an… |
Facility details
- Company
- Cynosure, LLC
- Location
- Westford, MA (US)
- Source
- device