FDA Inspection
Osmed GmbhOsmed Gmbh – FDA Inspection, Jul 28, 2011
Record Details
This FDA Inspection record concerns Osmed Gmbh, with an inspection on July 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Osmed Gmbh
- Inspection Date
- July 28, 2011
- Product Type
- Devices
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ID · 19e6855d-36d3-4db7-a4b3-cfde67535fce
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 738886
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product control
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