FDA Inspection
ClearLab US Inc.ClearLab US Inc. – FDA Inspection, Jul 29, 2010
Record Details
This FDA Inspection record concerns ClearLab US Inc., with an inspection on July 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ClearLab US Inc.
- Inspection Date
- July 29, 2010
- Product Type
- Devices
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ID · 3a1cc63f-5bc0-4bb5-8019-b5110016ee84
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676042
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 803.18(a)Event files -- failure to establish and maintain
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
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Other FDA inspections of ClearLab US Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 29, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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