FDA Inspection
3-D Matrix, Inc.3-D Matrix, Inc. – FDA Inspection, Nov 17, 2021
Record Details
This FDA Inspection record concerns 3-D Matrix, Inc., with an inspection on November 17, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 3-D Matrix, Inc.
- Inspection Date
- November 17, 2021
- Product Type
- Devices
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ID · 5ac48145-eff7-4042-a073-b02796c2aec5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1157734
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.40(b)Change records, content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of 3-D Matrix, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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