FDA Inspection
Avalon Biomed IncAvalon Biomed Inc – FDA Inspection, Jul 21, 2015
Record Details
This FDA Inspection record concerns Avalon Biomed Inc, with an inspection on July 21, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avalon Biomed Inc
- Inspection Date
- July 21, 2015
- Product Type
- Devices
View Company Profile
ID · a1ecc4ed-5780-490d-8db1-a05a6b195e0b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 934933
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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