FDA Inspection 653183 — Fenwal International, Inc.
The FDA completed an inspection of Fenwal International, Inc. on Mar 23, 2010 in Maricao, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 23, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maricao, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |