FDA Inspection
Puretone Ltd.Puretone Ltd. – FDA Inspection, Nov 20, 2008
Record Details
This FDA Inspection record concerns Puretone Ltd., with an inspection on November 20, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Puretone Ltd.
- Inspection Date
- November 20, 2008
- Product Type
- Devices
View Company Profile
ID · 8fffccd3-15ad-4c5d-9f44-f0f10ca68909
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 554189
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training
- 21 CFR 820.25(b)Training records
- 21 CFR 820.120(d)Mixups
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.30(e)Design review procedures - personnel
- 21 CFR 820.180(b)Retention period
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.184(e)ID label, labeling
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