FDA Inspection
BTS S.p.A.BTS S.p.A. – FDA Inspection, Nov 15, 2024
Record Details
This FDA Inspection record concerns BTS S.p.A., with an inspection on November 15, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · 049a0d14-2b72-4db7-9cb6-9f48cf2d430e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254216
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 801.20(a)Label to bear a unique device identifier
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 11, 2024 | VAI | Center for Devices and Radiological Health | Compliance: 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 1254142 - 2024-11-11
- FDA Inspection 1038426 - 2017-11-16
- FDA Inspection 915718 - 2015-02-05
- FDA Inspection 768404 - 2012-02-02
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.