FDA Inspection
Clinton River Medical Products, LLCClinton River Medical Products, LLC – FDA Inspection, Sep 8, 2017
Record Details
This FDA Inspection record concerns Clinton River Medical Products, LLC, with an inspection on September 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dce564cf-c69a-4c0c-9d41-233e3028bdba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024836
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Clinton River Medical Products, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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