FDA Inspection
S4 Medical CorpS4 Medical Corp – FDA Inspection, Nov 18, 2025
Record Details
This FDA Inspection record concerns S4 Medical Corp, with an inspection on November 18, 2025, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · 4608deee-e00f-4056-a112-900d879760d6
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1291752
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 820.30(c)Design input - documentation
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