FDA Inspection
Clearwater Products, LLCClearwater Products, LLC – FDA Inspection, Aug 25, 2009
Record Details
This FDA Inspection record concerns Clearwater Products, LLC, with an inspection on August 25, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Clearwater Products, LLC
- Inspection Date
- August 25, 2009
- Product Type
- Devices
View Company Profile
ID · d8defb68-a897-4a98-aa1d-9579bf1ca2a9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 608187
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(c)Incomplete, ambiguous, conflicting design requirements
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Clearwater Products, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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