Company
United StatesCurae'Lase, Inc., Loris, SC – FDA Inspections
Inspection records and compliance data for Curae'Lase, Inc. in Loris, South Carolina. 3 FDA inspections on record (1 OAI), last inspected February 05, 2018.
Company Profile
This profile covers Curae'Lase, Inc. based in Loris, South Carolina, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected April 7, 2011. Last inspected February 5, 2018.
Most cited issue areas
- DMR device specifications1 inspection
- DMR - not or inadequately maintained1 inspection
- Quality System Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 5, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1048581 |
| November 6, 2012 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 811634 |
| April 7, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 718668 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Curae'Lase, Inc.
FEI Number
3005535133
Address
2311 Highway 701 S, Loris, South Carolina 29569, United States
Country
United States
ID: 3a447af7-5ca6-4fc1-ae50-061fe35c0a34