FDA Inspection
BTS S.p.A.BTS S.p.A. – FDA Inspection, Feb 2, 2012
Record Details
This FDA Inspection record concerns BTS S.p.A., with an inspection on February 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BTS S.p.A.
- Inspection Date
- February 2, 2012
- Product Type
- Devices
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ID · fa479f28-cc47-459d-9440-4447deb2a92e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 768404
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17Lack of Written MDR 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 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 |
Other documents for BTS S.p.A.
- FDA Inspection 1254216 - 2024-11-15
- FDA Inspection 1254142 - 2024-11-11
- FDA Inspection 1038426 - 2017-11-16
- FDA Inspection 915718 - 2015-02-05
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