1151351
Technological Medical Advancements LLC — FEI 3009346095
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 9, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- West Palm Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5172 | 21 CFR 1040.10(g)(4) | Logotype label output information |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |