FDA Inspection 1047929 — Almitech, Inc.
The FDA completed an inspection of Almitech, Inc. on Mar 30, 2018 in Bellmore, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 30, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bellmore, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |