FDA Inspection 1230528 — Phoenix Thera-Lase Systems LLC
The FDA completed an inspection of Phoenix Thera-Lase Systems LLC on June 3, 2024 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 3, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 5031 | 21 CFR 1010.2(a) | Lack of certification of conformance |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5042 | 21 CFR 1010.3(a) | ID label or tag |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5811 | 21 CFR 1002.30(a)(1) | Quality control procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |