FDA Inspection 718668 — Curae'Lase, Inc.
The FDA completed an inspection of Curae'Lase, Inc. on April 7, 2011 in Loris, SC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 7, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Loris, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |