FDA Inspection 667405 — Activa Brand Products, Inc.
The FDA completed an inspection of Activa Brand Products, Inc. on May 27, 2010 in Cornwall. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 27, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cornwall (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |