FDA Inspection
Fenwal International Inc.Fenwal International Inc. – FDA Inspection, Mar 4, 2024
Record Details
This FDA Inspection record concerns Fenwal International Inc., with an inspection on March 4, 2024, issued by the San Juan District Office, covering biologics.
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ID · 24e65c54-f080-4c09-b0f4-ef04c30b0c5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1231736
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Fenwal International Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 13, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 17, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fenwal International Inc.
- FDA Inspection 969766 - 2016-03-21
- FDA Inspection 818407 - 2013-02-13
- FDA Inspection 716648 - 2011-03-17
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