FDA Inspection
MDI East Inc., DBA AptyxMDI East Inc., DBA Aptyx – FDA Inspection, May 21, 2026
Record Details
This FDA Inspection record concerns MDI East Inc., DBA Aptyx, with an inspection on May 21, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · d9b39ebd-f757-4caf-830a-341160d1ba3d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1318098
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 801.20(a)Label to bear a unique device identifier
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of MDI East Inc., DBA Aptyx
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 7, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MDI East Inc., DBA Aptyx
- FDA Inspection 887945 - 2014-07-23
- FDA Inspection 718506 - 2011-04-07
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