FDA Inspection
Fenwal International, Inc.Fenwal International, Inc. – FDA Inspection, Apr 25, 2013
Record Details
This FDA Inspection record concerns Fenwal International, Inc., with an inspection on April 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fenwal International, Inc.
- Inspection Date
- April 25, 2013
- Product Type
- Devices
View Company Profile
ID · 6df2d9af-f2fe-4148-b893-1653002a6348
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 828922
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fenwal International, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2026 | Not classified | San Juan District Office | Blood and Blood Products |
| September 18, 2024 | VAI | San Juan District Office | Blood and Blood Products |
| September 24, 2022 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 24, 2021 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 26, 2019 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Fenwal International, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.