FDA Inspection
Norseld Pty LtdNorseld Pty Ltd – FDA Inspection, Jul 5, 2013
Record Details
This FDA Inspection record concerns Norseld Pty Ltd, with an inspection on July 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Norseld Pty Ltd
- Inspection Date
- July 5, 2013
- Product Type
- Devices
View Company Profile
ID · ac733db0-916d-4a50-b178-1f1d1a7b75fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842690
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Norseld Pty Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Norseld Pty Ltd
- FDA Inspection 983858 - 2016-07-14
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