Company
United StatesGenova Diagnostics, Asheville, NC – FDA Inspections
Inspection records and compliance data for Genova Diagnostics in Asheville, North Carolina. 1 FDA inspection on record, 1 Form 483, last inspected February 24, 2017.
Company Profile
This profile covers Genova Diagnostics based in Asheville, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected February 24, 2017.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 24, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1009292 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Genova Diagnostics
FEI Number
1000111208
Address
63 Zillicoa St, Asheville, North Carolina 28801, United States
Country
United States
ID: 9d90aa38-ff52-4e7d-9f37-10b720ba15af