FDA Inspection 614070 — Penumbra Inc.
The FDA completed an inspection of Penumbra Inc. on August 28, 2009 in Alameda, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 28, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Alameda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4189 | 21 CFR 820.198(a) | General |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |