Animal feed that was produced by Templeton Feed & Grain Inc., a medicated feed mill in Templeton, CA, is unsafe and adulterated, according to the U.S. Food and Drug Administration (FDA).
In a recently released April 13 warning letter to Templeton Feed & Grain, FDA said a Nov. 3-6, 2009 inspection found “significant deviations” from Current Good Manufacturing Practice regulations for medicated feed.
“Furthermore, this inspection documented the use of a Type A medicated article, containing the drug sulfamethazine, contrary to its new animal drug application (NADA), NADA 035-688,” wrote Alonza E. Cruse, FDA’s Los Angeles district director.
“When sulfamethazine was used in animal feed labeled as containing sulfathiazole, this drug and the animal feed containing the drug were deemed to be unsafe…and adulterated…and misbranded…” he added.
Sulfamethazine is primarily used as a veterinary antibacterial drug for food animals. Feed containing it is supposed to carry a warning that it should be withdrawn from use 15 days prior to slaughter.
Templeton’s “Pig Starter & Grow Medicated Feed” label said: “Warning: withdraw 7 days prior to slaughter.” FDA called that labeling false and misleading.
It is not the first time that Templeton has had these problems.
“Your firm did not perform periodic assays for each drug or drug combination used during the calendar year on at least three representative samples of medicated feeds requiring a medicated feed mill license…” Cruse wrote. “You were notified of this deficiency during a previous inspection and in the Warning Letter issued to your firm on March 22, 2000.”
He said there was no record of a sample being taken from any of the three four-ton lots of Pig Starter & Grow Medicated Feed that were manufactured on specific dates. Nor was there any evidence that Templeton conducted an investigation or took corrective action when assay results showed that its medicated feed did not meet drug concentrations that were specified.
Minimum label amounts for the sulfa drug were not correct, FDA said.
The deadline for Templeton’s response to FDA has passed. The agency said it wanted the problems corrected within 30 days. The case has not yet be “closed out,” according to FDA’s Website.