FDA Inspection
Fenwal International, Inc.Fenwal International, Inc. – FDA Inspection, Feb 24, 2012
Record Details
This FDA Inspection record concerns Fenwal International, Inc., with an inspection on February 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fenwal International, Inc.
- Inspection Date
- February 24, 2012
- Product Type
- Devices
View Company Profile
ID · bdd997e9-00a6-4257-8b9e-d1a4755f1ff9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769057
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 314.81(b)(1)(i)Mix-up
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Extent of discrepancy, failure investigations
Full citation text and observation details available on the Dashboard.
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