Company
BrazilIbramed Industria Brasileira de Equipamentos Medicos Ltda, Amparo, Brazil – FDA Inspections
Inspection records and compliance data for Ibramed Industria Brasileira de Equipamentos Medicos Ltda in Amparo. 2 FDA inspections on record, 1 Form 483, last inspected January 23, 2025.
Company Profile
This profile covers Ibramed Industria Brasileira de Equipamentos Medicos Ltda based in Amparo, Brazil.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 26, 2017. Last inspected January 23, 2025.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 23, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1262511 |
| October 26, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1030632 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ibramed Industria Brasileira de Equipamentos Medicos Ltda
FEI Number
3010362721
Address
Avenida Doutor Carlos Burgos, 2800, Amparo, Brazil
Country
Brazil
ID: 57e59ee7-74b6-446f-9a00-05b993080d06