FDA Inspection
Gambro Renal Products S.A. de C.V.Gambro Renal Products S.A. de C.V. – FDA Inspection, Feb 19, 2009
Record Details
This FDA Inspection record concerns Gambro Renal Products S.A. de C.V., with an inspection on February 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 19, 2009
- Product Type
- Devices
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ID · f6024ff5-1493-471b-8d8b-e6e635c9dd40
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 570585
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.250(b)Sampling plans
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