FDA Inspection 1168576 — Nu Dimension Tech Ventures, Llc
The FDA completed an inspection of Nu Dimension Tech Ventures, Llc on May 4, 2022 in Huffman, TX. 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). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Huffman, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |