FDA Inspection 828922 — Fenwal International, Inc.
The FDA completed an inspection of Fenwal International, Inc. on Apr 25, 2013 in Maricao, PR. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 25, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maricao, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |