FDA Inspection 1318098 — MDI East Inc., DBA Aptyx
The FDA completed an inspection of MDI East Inc., DBA Aptyx on May 21, 2026 in South Glens Falls, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- South Glens Falls, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |