Company
United StatesCandela Corporation, Marlborough, MA – FDA Inspections
Inspection records and compliance data for Candela Corporation in Marlborough, Massachusetts. 4 FDA inspections on record, 2 Form 483s, last inspected November 17, 2017.
Company Profile
This profile covers Candela Corporation based in Marlborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 18, 2011. Last inspected November 17, 2017.
Most cited issue areas
- Acceptance status1 inspection
- DHR - not or inadequately maintained1 inspection
- Documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2017 | Not classified | Medical Devices & Rad Health | 1048083 |
| February 8, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1002942 |
| February 21, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 868362 |
| October 18, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 752274 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Candela Corporation
FEI Number
1218402
Address
251 Locke Dr, Marlborough, Massachusetts 01752-7220, United States
Country
United States
ID: 17da0021-1ef2-48bf-b786-70bd590e80b5