Company
BrazilSIGVARIS DO BRASIL IND. E COM. LTDA, Jundiai, Brazil – FDA Inspections
Inspection records and compliance data for SIGVARIS DO BRASIL IND. E COM. LTDA in Jundiai. 4 FDA inspections on record, last inspected March 07, 2024.
Company Profile
This profile covers SIGVARIS DO BRASIL IND. E COM. LTDA based in Jundiai, Brazil.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected September 6, 2012. Last inspected March 7, 2024.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Equipment control activity documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 7, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1235488 |
| March 16, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1012425 |
| February 4, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 912876 |
| September 6, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 800343 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SIGVARIS DO BRASIL IND. E COM. LTDA
FEI Number
3004903147
Address
Avenida Jose Benassi, 2323, Distrito Industrial Fazgran, Jundiai, Brazil
Country
Brazil
ID: 4911a82f-15ff-4101-8313-6b08364af310