FDA Inspection
Physiomed Elektromedizin AGPhysiomed Elektromedizin AG – FDA Inspection, Nov 7, 2014
Record Details
This FDA Inspection record concerns Physiomed Elektromedizin AG, with an inspection on November 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Physiomed Elektromedizin AG
- Inspection Date
- November 7, 2014
- Product Type
- Devices
View Company Profile
ID · fdeee083-e704-4662-8c2f-8cea7ff31a15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904773
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
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