FDA Inspection
European Custom Manufacturing B.V/ Medical Concepts EuropeEuropean Custom Manufacturing B.V/ Medical Concepts Europe – FDA Inspection, Feb 16, 2012
Record Details
This FDA Inspection record concerns European Custom Manufacturing B.V/ Medical Concepts Europe, with an inspection on February 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 16, 2012
- Product Type
- Devices
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ID · 93eb2d46-8e72-45be-b3d7-26ce964c059f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770511
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
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