FDA Inspection
Fleming Laboratories, Inc.Fleming Laboratories, Inc. – FDA Inspection, Mar 17, 2017
Record Details
This FDA Inspection record concerns Fleming Laboratories, Inc., with an inspection on March 17, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
- People
- Larry K. Hampton (Company Rep)
- Rachael L. Derby (Issuing Officer)
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ID · 7324fcca-fb92-4a95-b631-eaca91cb88a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005181
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 211.80(c)Storage off Floor, Spaced Suitably
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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Other FDA inspections of Fleming Laboratories, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2014 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 22, 2011 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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