FDA Inspection
Aptyx Charlotte, LLCAptyx Charlotte, LLC – FDA Inspection, Mar 29, 2024
Record Details
This FDA Inspection record concerns Aptyx Charlotte, LLC, with an inspection on March 29, 2024, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · 1dfdfa30-73f8-4c11-a7f6-5b5b6bfdf9e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1234427
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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 |
| 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 1295444 - 2025-12-15
- FDA Inspection 1115152 - 2019-12-11
- FDA Inspection 969967 - 2016-03-21
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