FDA Inspection
Clareblend, Inc.Clareblend, Inc. – FDA Inspection, Jun 8, 2018
Record Details
This FDA Inspection record concerns Clareblend, Inc., with an inspection on June 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a2324f9f-8f09-460d-b093-8384dce06a74
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1055147
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.100(b)Documentation
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.180Availability
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
Showing 10 of 11 citations.
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Other FDA inspections of Clareblend, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 14, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Clareblend, Inc.
- FDA Inspection 937413 - 2015-07-17
- FDA Inspection 806360 - 2012-11-14
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