FDA Inspection
Aldagen, Inc.Aldagen, Inc. – FDA Inspection, Sep 18, 2009
Record Details
This FDA Inspection record concerns Aldagen, Inc., with an inspection on September 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aldagen, Inc.
- Inspection Date
- September 18, 2009
- Product Type
- Devices
View Company Profile
ID · c8ebf427-c1ae-4100-855a-27e5c9239cd8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613858
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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