FDA Inspection
Advanced Medical Technologies AGAdvanced Medical Technologies AG – FDA Inspection, Apr 7, 2011
Record Details
This FDA Inspection record concerns Advanced Medical Technologies AG, with an inspection on April 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 7, 2011
- Product Type
- Devices
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ID · f78d3ed3-ae0a-4f36-98d4-2a0c757bed68
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 722502
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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