FDA Inspection
Handicare Usa IncHandicare Usa Inc – FDA Inspection, May 2, 2013
Record Details
This FDA Inspection record concerns Handicare Usa Inc, with an inspection on May 2, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Handicare Usa Inc
- Inspection Date
- May 2, 2013
- Product Type
- Devices
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ID · da84f6c2-cb2c-49d1-bb5e-8f8ee61fceef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 829716
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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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 |
| December 16, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 906313 - 2014-12-16
- FDA Inspection 723426 - 2011-05-04
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