Cynosure, Inc. — FDA Facility Profile
Cynosure, Inc. is an FDA-inspected facility (FEI 2428235) located in Hicksville, NY, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Aug 7, 2014: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 VAI, 1 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
- 1, latest Sep 7, 2016
- Import refusals
- 3
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 7, 2014 | Voluntary Action Indicated (VAI) | Acceptable supplier records, inadequate records (21 CFR 820.50(a)(3)) Design plans- updated (21 CFR 820.30(b)) |
| May 11, 2012 | Voluntary Action Indicated (VAI) | Acceptable supplier records, inadequate records (21 CFR 820.50(a)(3)) Documentation (21 CFR 820.100(b)) |
| May 26, 2010 | No Action Indicated (NAI) | Process control instructions (21 CFR 820.70(a)(1)) Environmental control Lack of or inadequate procedures (21 CFR 820.70(c)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 7, 2016 | Class II | Z-0748-2017 | ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable… Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on… |
Facility details
- Company
- Cynosure, Inc.
- Location
- Hicksville, NY (US)
- Source
- inspections