FDA Inspection
Handicare Usa IncHandicare Usa Inc – FDA Inspection, Dec 16, 2014
Record Details
This FDA Inspection record concerns Handicare Usa Inc, with an inspection on December 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Handicare Usa Inc
- Inspection Date
- December 16, 2014
- Product Type
- Devices
View Company Profile
ID · 9ba08a4c-0742-4113-9d4f-d66d1a72a49d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906313
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Handicare Usa Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 2, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 4, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Handicare Usa Inc
- FDA Inspection 958331 - 2016-01-27
- FDA Inspection 829716 - 2013-05-02
- FDA Inspection 723426 - 2011-05-04
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