FDA Inspection 839303 — Batrik Medical Mfg., Inc.
The FDA completed an inspection of Batrik Medical Mfg., Inc. on Jun 27, 2013 in Lachine. 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
- Jun 27, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lachine (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3159 | 21 CFR 820.184 | DHR content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |