FDA Inspection
Aptyx Charlotte, LLCAptyx Charlotte, LLC – FDA Inspection, Dec 15, 2025
Record Details
This FDA Inspection record concerns Aptyx Charlotte, LLC, with an inspection on December 15, 2025, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · 8190b65e-ac55-4dda-a33d-49d9e8a3b6fa
Inspection Facts
- Inspection number
- 1295444
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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 | |
| March 29, 2024 | VAI | Atlanta District Office | Project Evaluation: Devices |
| December 11, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 21, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aptyx Charlotte, LLC
- FDA Inspection 1316142 - 2026-05-05
- FDA Inspection 1234427 - 2024-03-29
- FDA Inspection 1115152 - 2019-12-11
- FDA Inspection 969967 - 2016-03-21
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