FDA Inspection
Astute Choice PackagingAstute Choice Packaging – FDA Inspection, Dec 10, 2009
Record Details
This FDA Inspection record concerns Astute Choice Packaging, with an inspection on December 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Astute Choice Packaging
- Inspection Date
- December 10, 2009
- Product Type
- Devices
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ID · e0335503-07cc-4f3c-89d2-331e670a87e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 633117
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Astute Choice Packaging
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Astute Choice Packaging
- FDA Inspection 1103441 - 2019-09-30
- FDA Inspection 827533 - 2013-04-12
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