FDA Inspection
Astute Choice PackagingAstute Choice Packaging – FDA Inspection, Sep 30, 2019
Record Details
This FDA Inspection record concerns Astute Choice Packaging, with an inspection on September 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ea27323e-0da3-42bc-ac61-ef90a45a0a8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1103441
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.40(a)Document review, approval documentation
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Other FDA inspections of Astute Choice Packaging
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 10, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Astute Choice Packaging
- FDA Inspection 827533 - 2013-04-12
- FDA Inspection 633117 - 2009-12-10
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