FDA Inspection
Aptyx Charlotte, LLCAptyx Charlotte, LLC – FDA Inspection, Mar 21, 2016
Record Details
This FDA Inspection record concerns Aptyx Charlotte, LLC, with an inspection on March 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aptyx Charlotte, LLC
- Inspection Date
- March 21, 2016
- Product Type
- Devices
View Company Profile
ID · f4c1c690-cedb-4630-9367-561f706cbe9d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969967
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.184DHR - not or inadequately maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Aptyx Charlotte, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2026 | Not classified | Atlanta District Office | |
| December 15, 2025 | Not classified | Atlanta District Office | Postmarket Assurance: Medical Devices |
| March 29, 2024 | VAI | Atlanta District Office | Project Evaluation: Devices |
| December 11, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Aptyx Charlotte, LLC
- FDA Inspection 1316142 - 2026-05-05
- FDA Inspection 1295444 - 2025-12-15
- FDA Inspection 1234427 - 2024-03-29
- FDA Inspection 1115152 - 2019-12-11
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