FDA Inspection
Excel Regenerative SolutionsExcel Regenerative Solutions – FDA Inspection, Oct 6, 2010
Record Details
This FDA Inspection record concerns Excel Regenerative Solutions, with an inspection on October 6, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Excel Regenerative Solutions
- Inspection Date
- October 6, 2010
- Product Type
- Devices
View Company Profile
ID · 185da44e-115f-4b0f-9a5e-923f3987793e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 685023
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Excel Regenerative Solutions
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 21, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Excel Regenerative Solutions
- FDA Inspection 750984 - 2011-10-21
- FDA Inspection 672790 - 2010-07-22
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