FDA Inspection
Kaz USA, Inc.Kaz USA, Inc. – FDA Inspection, Jul 1, 2013
Record Details
This FDA Inspection record concerns Kaz USA, Inc., with an inspection on July 1, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kaz USA, Inc.
- Inspection Date
- July 1, 2013
- Product Type
- Devices
View Company Profile
ID · e3e51767-b6d4-49cc-a7f6-f3c45140bcce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838795
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Kaz USA, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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