FDA Inspection
Ibramed Industria Brasileira de Equipamentos Medicos LtdaIbramed Industria Brasileira de Equipamentos Medicos Ltda – FDA Inspection, Oct 26, 2017
Record Details
This FDA Inspection record concerns Ibramed Industria Brasileira de Equipamentos Medicos Ltda, with an inspection on October 26, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- October 26, 2017
- Product Type
- Medical Devices & Rad Health
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ID · 65f971ca-a9f4-4867-8a77-2f5a1c936da1
Inspection Facts
- Inspection number
- 1030632
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of Ibramed Industria Brasileira de Equipamentos Medicos Ltda
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ibramed Industria Brasileira de Equipamentos Medicos Ltda
- FDA Inspection 1262511 - 2025-01-23
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