Company
United StatesAptyx Charlotte, LLC, Charlotte, NC – FDA Inspections
Inspection records and compliance data for Aptyx Charlotte, LLC in Charlotte, North Carolina. 5 FDA inspections on record, 2 Form 483s, last inspected May 05, 2026.
Company Profile
This profile covers Aptyx Charlotte, LLC based in Charlotte, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected March 21, 2016. Last inspected May 5, 2026.
Most cited issue areas
- Design review - documentation1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 5, 2026 | Not classified | Medical Devices & Rad Health | 1316142 |
| December 15, 2025 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1295444 |
| March 29, 2024 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1234427 |
| December 11, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1115152 |
| March 21, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 969967 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Aptyx Charlotte, LLC
FEI Number
3011324393
Address
8531 Steele Creek Place Dr Ste D, Charlotte, North Carolina 28273, United States
Country
United States
ID: 79dd0ba8-90df-4c3a-a932-38128b8534f5