FDA Inspection
Clareblend, Inc.Clareblend, Inc. – FDA Inspection, Jul 17, 2015
Record Details
This FDA Inspection record concerns Clareblend, Inc., with an inspection on July 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Clareblend, Inc.
- Inspection Date
- July 17, 2015
- Product Type
- Devices
View Company Profile
ID · 674fd91e-022e-415d-a48d-0e07b404fc72
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 937413
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.180Availability
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Clareblend, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2018 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| November 14, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Clareblend, Inc.
- FDA Inspection 1055147 - 2018-06-08
- FDA Inspection 806360 - 2012-11-14
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