FDA Inspection 718506 — MDI East Inc., DBA Aptyx
The FDA completed an inspection of MDI East Inc., DBA Aptyx on April 7, 2011 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 7, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- South Glens Falls, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |