FDA Inspection
3-D Matrix, Inc.3-D Matrix, Inc. – FDA Inspection, Oct 18, 2023
Record Details
This FDA Inspection record concerns 3-D Matrix, Inc., with an inspection on October 18, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9aa475f2-feed-435a-972a-8fc6b7f6431a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220875
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of 3-D Matrix, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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