FDA Inspection
Sophysa S.A.Sophysa S.A. – FDA Inspection, Jun 12, 2025
Record Details
This FDA Inspection record concerns Sophysa S.A., with an inspection on June 12, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 267a2d8d-a13c-44cd-a6cf-203399fbaba2
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1276306
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
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Other FDA inspections of Sophysa S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sophysa S.A.
- FDA Inspection 1086004 - 2019-01-31
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