FDA Inspection 1157734 — 3-D Matrix, Inc.
The FDA completed an inspection of 3-D Matrix, Inc. on Nov 17, 2021 in Newton, MA. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 17, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Newton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |