FDA Inspection
Mixpak IncMixpak Inc – FDA Inspection, Apr 12, 2012
Record Details
This FDA Inspection record concerns Mixpak Inc, with an inspection on April 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mixpak Inc
- Inspection Date
- April 12, 2012
- Product Type
- Devices
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ID · d2d58546-d4bc-44ae-b20c-bd0808b6a211
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 776761
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Mixpak Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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