May 31, 2010
Templeton found to violate GMP regulations for medicated feed
Animal feed that was produced by Templeton Feed & Grain Inc., a medicated feedmill in Templeton, California, is unsafe and adulterated, according to the US Food and Drug Administration (FDA).
FDA warned Templeton in letter in April saying the November 3-6, 2009 inspection found "significant deviations" from Current Good Manufacturing Practice regulations for medicated feed.
This inspection documented the use of a Type A medicated article, containing the drug sulfamethazine, contrary to its new animal drug application, NADA 035-688.
Sulfamethazine was used in animal feed labelled as containing sulfathiazole. This drug and the animal feed containing the drug were deemed to be unsafe, adulterated and misbranded.
Sulfamethazine is primarily used as a veterinary antibacterial drug for food animals as has a withdrawal period of 15 days prior to slaughter. The feed is supposed to carry this warning.
Templeton''s "Pig Starter & Grow Medicated Feed" label said, "Warning: withdraw seven days prior to slaughter." FDA called that labelling false and misleading.
FDA said there was no record of a sample being taken from any of the three four-tonne lots of the 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.