FDA Inspection
FEG Textiltechnik mbHFEG Textiltechnik mbH – FDA Inspection, Aug 20, 2015
Record Details
This FDA Inspection record concerns FEG Textiltechnik mbH, with an inspection on August 20, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- FEG Textiltechnik mbH
- Inspection Date
- August 20, 2015
- Product Type
- Devices
View Company Profile
ID · 8dd7392c-ca58-4345-8c8b-47b2e672bd78
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 942106
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.184DHR content
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