FDA Inspection
Voss Medical ProductsVoss Medical Products – FDA Inspection, Sep 12, 2014
Record Details
This FDA Inspection record concerns Voss Medical Products, with an inspection on September 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Voss Medical Products
- Inspection Date
- September 12, 2014
- Product Type
- Devices
View Company Profile
ID · 9bd40b7a-c012-4b18-8f21-584e533843cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 896787
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Voss Medical Products
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2024 | Not classified | Dallas District Office | |
| March 4, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Voss Medical Products
- FDA Inspection 1246374 - 2024-08-06
- FDA Inspection 963330 - 2016-03-04
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