FDA Inspection
Animal Health International, Inc dba Lextron, IncAnimal Health International, Inc dba Lextron, Inc – FDA Inspection, Aug 30, 2010
Record Details
This FDA Inspection record concerns Animal Health International, Inc dba Lextron, Inc, with an inspection on August 30, 2010, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- August 30, 2010
- Product Type
- Veterinary
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ID · 38180d35-069a-46eb-8a5b-57bc974e2bc8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680930
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
13- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(b)Test method modification records do not include
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 1271.160(d)Computer software verification
- 21 CFR 211.22(a)Lack of quality control unit
Showing 10 of 13 citations.
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Other FDA inspections of Animal Health International, Inc dba Lextron, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 7, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 26, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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