Bovine practitioners recount experiences with FDA inspections

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No bovine practitioner wants inspectors from the Food and Drug Administration to be the ones who point out problems with a client's pharmaceutical use.

So said Dr. Scott T. Smith of the Dairy Authority in Greeley, Colo. Dr. Smith is one of two veterinarians who, during the recent conference of the American Association of Bovine Practioners, spoke about experiences with FDA inspection of dairies following a finding of violative drug residues in cows culled from the dairies.

Dr. Daniel E. Little of DairyNet consulting group in Brookings, S.D., recounted the case of a dairy that turned to him for assistance when the FDA came calling regarding violative drug residues.

The FDA's first actions were an inspection and warning letter. The dairy did not keep written treatment records and protocols and did not maintain temperature and inventory control for drugs. The prescribing veterinarian visited only annually. Dr. Little began monthly visits as he worked with the dairy to address deficiencies.

Another violative drug residue led to a second FDA inspection. The inspector asserted that a veterinarian-client-patient relationship required Dr. Little to have knowledge of all antimicrobials on the farm, including over-the-counter drugs. The FDA dropped the allegations after Dr. Little disputed them, however.

Six months after the second inspection, the dairy received a letter from a U.S. district court with a consent decree of permanent injunction not to sell meat or milk until the operation met certain terms. Among the terms were that the operation meet record-keeping requirements as well as provide buyers with treatment histories for each animal for the past 60 days and obtain signatures to show the buyers received the information.

Dr. Little concluded with general advice for preventing violative drug residues: "Document, document, document—and then train from all of that documentation so that people know what to do with those documents."

Dr. Smith of the Dairy Authority, who spoke second, said his encounter with FDA inspectors was humbling.

In 2007, a local slaughter facility found violative drug residues in cows from one of Dr. Smith's dairy clients. So he retrained the operation's workers and added urine screening for culled animals with a history of treatment.

Then, inspectors from the FDA paid a visit to the dairy and Dr. Smith. They asked him for his records of extralabel drug use, and he had to admit that he didn't have any.

Dr. Smith thinks the primary factors contributing to the violative drug residues at the dairy were poor record keeping, worker turnover, mislabeled products from suppliers, improper dosing by workers, and a misconception that flunixin meglumine would not cause a residue. The FDA inspection was what prompted the operation to start keeping complete records.

"We like to think of ourselves as sound practitioners who are doing a good job educating our clients and our farm workers to take care of these dairy cows and that they use all the procedures and all the protocols that we've laid out for them the right way every time," Dr. Smith said. "Every now and then we realize we have a system that's kind of crooked here and needs some attention."

Coverage of the AABP conference continues here.