FDA Inspection 1151351 — Technological Medical Advancements LLC
The FDA completed an inspection of Technological Medical Advancements LLC on Sep 9, 2021 in West Palm Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 9, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- 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 |