FDA Inspection
3D LifePrints USA Inc. D.B.A. Insight Surgery3D LifePrints USA Inc. D.B.A. Insight Surgery – FDA Inspection, Nov 15, 2024
Record Details
This FDA Inspection record concerns 3D LifePrints USA Inc. D.B.A. Insight Surgery, with an inspection on November 15, 2024, issued by the Dallas District Office, covering medical devices & rad health.
- Inspection Date
- November 15, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 234c9a9a-9345-48b8-b285-a2c7bfa68943
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1254228
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Design history file
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