FDA Inspection
Surgtech IncSurgtech Inc – FDA Inspection, May 7, 2025
Record Details
This FDA Inspection record concerns Surgtech Inc, with an inspection on May 7, 2025, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · 679ca498-972a-4de8-810e-f8ac20ace436
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1269576
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
4- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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