FDA Inspection
3D Medical Manufacturing, Inc.3D Medical Manufacturing, Inc. – FDA Inspection, May 10, 2019
Record Details
This FDA Inspection record concerns 3D Medical Manufacturing, Inc., with an inspection on May 10, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ecf92c4e-345a-4068-a00a-403de473bff5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091601
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of 3D Medical Manufacturing, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for 3D Medical Manufacturing, Inc.
- FDA Inspection 1179677 - 2022-09-15
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