FDA Inspection
BTS S.p.A.BTS S.p.A. – FDA Inspection, Nov 11, 2024
Record Details
This FDA Inspection record concerns BTS S.p.A., with an inspection on November 11, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · aadac72a-1b6a-4a61-8c3d-7f39a40bcb55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254142
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BTS S.p.A.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| November 16, 2017 | Not classified | Office of Inspections and Investigations | |
| February 5, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 2, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for BTS S.p.A.
- FDA Inspection 1254216 - 2024-11-15
- FDA Inspection 1038426 - 2017-11-16
- FDA Inspection 915718 - 2015-02-05
- FDA Inspection 768404 - 2012-02-02
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