FDA Inspection
Mixpak IncMixpak Inc – FDA Inspection, Nov 15, 2010
Record Details
This FDA Inspection record concerns Mixpak Inc, with an inspection on November 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mixpak Inc
- Inspection Date
- November 15, 2010
- Product Type
- Devices
View Company Profile
ID · a950fd4b-072d-41db-8524-848045db4956
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 698628
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
17- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Showing 10 of 17 citations.
Full citation text and observation details available on the Dashboard.
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 4, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mixpak Inc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.