Company
ItalyBTS S.p.A., Vigonza, Italy – FDA Inspections
Inspection records and compliance data for BTS S.p.A. in Vigonza. 5 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected November 15, 2024.
Company Profile
This profile covers BTS S.p.A. based in Vigonza, Italy.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected February 2, 2012. Last inspected November 15, 2024.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design validation - documentation1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1254216 |
| November 11, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1254142 |
| November 16, 2017 | Not classified | Medical Devices & Rad Health | 1038426 |
| February 5, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 915718 |
| February 2, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 768404 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
BTS S.p.A.
FEI Number
3005998761
Address
Via Capriccio 3/A, Vigonza, Italy
Country
Italy
ID: 8bd0b95b-cd2e-43b5-92e4-73671cdcb6ec