FDA Inspection
Via BiomedicalVia Biomedical – FDA Inspection, Oct 24, 2008
Record Details
This FDA Inspection record concerns Via Biomedical, with an inspection on October 24, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Via Biomedical
- Inspection Date
- October 24, 2008
- Product Type
- Devices
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ID · 95c8401b-7090-4ea2-adfd-90c48453f6c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 542600
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)General
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Via Biomedical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Via Biomedical
- FDA Inspection 749224 - 2011-10-14
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