Feedmill violated GMP regulations for medicated feed

FDA warned Templeton in letter in April saying the a Nov. 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 7 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-ton 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.

 

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.