FDA Inspection
3D Medical Manufacturing, Inc.3D Medical Manufacturing, Inc. – FDA Inspection, Aug 23, 2019
Record Details
This FDA Inspection record concerns 3D Medical Manufacturing, Inc., with an inspection on August 23, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8db21a23-3a37-4c5f-86d2-1bdd119e5b8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100704
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of 3D Medical Manufacturing, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2025 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| June 23, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 8, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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