FDA Inspection
Clearwater Products, LLCClearwater Products, LLC – FDA Inspection, Nov 15, 2010
Record Details
This FDA Inspection record concerns Clearwater Products, LLC, with an inspection on November 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Clearwater Products, LLC
- Inspection Date
- November 15, 2010
- Product Type
- Devices
View Company Profile
ID · a5972551-949c-47bb-9f8f-53db7834de97
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 697635
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Showing 10 of 11 citations.
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Other FDA inspections of Clearwater Products, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2009 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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