FDA Inspection
SOADCO, S.L.SOADCO, S.L. – FDA Inspection, Mar 7, 2025
Record Details
This FDA Inspection record concerns SOADCO, S.L., with an inspection on March 7, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · 705c5f11-8c8d-4e4e-8e1d-0205934c0d26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1263483
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SOADCO, S.L.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for SOADCO, S.L.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.