FDA Inspection
Chellew Clinical Outsourcing, LLCChellew Clinical Outsourcing, LLC – FDA Inspection, Oct 25, 2012
Record Details
This FDA Inspection record concerns Chellew Clinical Outsourcing, LLC, with an inspection on October 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 25, 2012
- Product Type
- Devices
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ID · a943d4a0-463b-4394-9bf2-14f5c55dc641
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 806341
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
- 21 CFR 812.140(b)(6)Other sponsor records required by FDA inadequate
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Other FDA inspections of Chellew Clinical Outsourcing, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Chellew Clinical Outsourcing, LLC
- FDA Inspection 948169 - 2015-10-16
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