FDA Inspection
Fenwal International, Inc.Fenwal International, Inc. – FDA Inspection, Mar 23, 2010
Record Details
This FDA Inspection record concerns Fenwal International, Inc., with an inspection on March 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fenwal International, Inc.
- Inspection Date
- March 23, 2010
- Product Type
- Devices
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ID · ff846b38-6752-4f3b-8888-c1e895bdd3c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653183
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Written record of investigation incomplete
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