FDA Inspection
Laboratorios B. Braun S.A.Laboratorios B. Braun S.A. – FDA Inspection, Feb 24, 2011
Record Details
This FDA Inspection record concerns Laboratorios B. Braun S.A., with an inspection on February 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Laboratorios B. Braun S.A.
- Inspection Date
- February 24, 2011
- Product Type
- Devices
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ID · d7495ec9-daa7-4ce3-9e4f-8a3daa71befa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 716632
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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