FDA Inspection
Alpha Genetics, Inc.Alpha Genetics, Inc. – FDA Inspection, Jan 26, 2009
Record Details
This FDA Inspection record concerns Alpha Genetics, Inc., with an inspection on January 26, 2009, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Alpha Genetics, Inc.
- Inspection Date
- January 26, 2009
- Product Type
- Veterinary
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ID · ee75b69a-bf1f-44a8-8f6b-583c77251485
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 559661
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
11- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Showing 10 of 11 citations.
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Other FDA inspections of Alpha Genetics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2012 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 28, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Alpha Genetics, Inc.
- FDA Inspection 798947 - 2012-09-13
- FDA Inspection 746722 - 2011-09-28
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