FDA Inspection
Mixpak IncMixpak Inc – FDA Inspection, Nov 4, 2008
Record Details
This FDA Inspection record concerns Mixpak Inc, with an inspection on November 4, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mixpak Inc
- Inspection Date
- November 4, 2008
- Product Type
- Drugs
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ID · b690fec6-854a-4bb3-aff8-2c5c900e3f04
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 546014
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Mixpak Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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