FDA Inspection 1147953 — CureWave Lasers, LLC
The FDA completed an inspection of CureWave Lasers, LLC on Aug 5, 2021 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 5, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5207 | 21 CFR 1040.11(a)(1) | Med. laser compliance, measurement |
| 5208 | 21 CFR 1040.11(a)(2) | Calibration of measurement system |
| 5209 | 21 CFR 1040.11(a)(3) | Aperture label |