FDA Inspection
LSO Medical S.A.SLSO Medical S.A.S – FDA Inspection, Oct 24, 2019
Record Details
This FDA Inspection record concerns LSO Medical S.A.S, with an inspection on October 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LSO Medical S.A.S
- Inspection Date
- October 24, 2019
- Product Type
- Devices
View Company Profile
ID · aee4fec3-0dea-4169-b895-15313d3071fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1107364
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LSO Medical S.A.S
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2013 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for LSO Medical S.A.S
- FDA Inspection 832273 - 2013-05-24
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