FDA Inspection
21st Century Oncology, LLC21st Century Oncology, LLC – FDA Inspection, Apr 6, 2012
Record Details
This FDA Inspection record concerns 21st Century Oncology, LLC, with an inspection on April 6, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- 21st Century Oncology, LLC
- Inspection Date
- April 6, 2012
- Product Type
- Biologics
View Company Profile
ID · 721d2529-8c0e-4ba7-bdd0-a2284b05cd01
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775841
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of 21st Century Oncology, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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