Company
United StatesAblexan Corporation, Raleigh, NC – FDA Inspections
Inspection records and compliance data for Ablexan Corporation in Raleigh, North Carolina. 5 FDA inspections on record, 1 Form 483, last inspected October 29, 2025.
Company Profile
This profile covers Ablexan Corporation based in Raleigh, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 20, 2011. Last inspected October 29, 2025.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Quality audits - auditor independence1 inspection
- Quality Audits - defined intervals1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 29, 2025 | Not classified | Medical Devices & Rad Health | 1290038 |
| January 23, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1195681 |
| November 7, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 993193 |
| January 14, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 863103 |
| July 20, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 737046 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ablexan Corporation
FEI Number
3007798534
Address
7424 Chapel Hill Rd, Raleigh, North Carolina 27607, United States
Country
United States
ID: 5c7b8466-c8c6-4333-96b9-af4bf25bba8e