Company
United StatesAldagen, Inc., Durham, NC – FDA Inspections
Inspection records and compliance data for Aldagen, Inc. in Durham, North Carolina. 1 FDA inspection on record, last inspected September 18, 2009.
Company Profile
This profile covers Aldagen, Inc. based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected September 18, 2009.
Most cited issue areas
- CAPA verification/validation of corrective/preventive action1 inspection
- Design validation acceptance criteria1 inspection
- Design validation - documentation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 613858 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Aldagen, Inc.
FEI Number
3006215860
Address
2810 Meridian Pkwy Ste 148, Durham, North Carolina 27713, United States
Country
United States
ID: 990cc3d6-81fc-4643-8a1c-b3ea3d7767a0