FDA Inspection
Animal Health International, Inc dba Lextron, IncAnimal Health International, Inc dba Lextron, Inc – FDA Inspection, Aug 26, 2011
Record Details
This FDA Inspection record concerns Animal Health International, Inc dba Lextron, Inc, with an inspection on August 26, 2011, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- August 26, 2011
- Product Type
- Veterinary
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ID · d99de27e-ce4c-4989-a575-dff90abef087
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 742873
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.150Written distribution procedure
Showing 10 of 11 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 30, 2010 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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