FDA Inspection
Auric Hoersysteme Gmbh & Co.kgAuric Hoersysteme Gmbh & Co.kg – FDA Inspection, Nov 12, 2009
Record Details
This FDA Inspection record concerns Auric Hoersysteme Gmbh & Co.kg, with an inspection on November 12, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 12, 2009
- Product Type
- Devices
View Company Profile
ID · a484ad77-0f16-401a-b668-471e1df16432
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 629680
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(c)Design input approval documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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