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dwerten · 06-12-2009, 07:55 PM

http://www.fda.gov/AnimalVeterinary/.../ucm166265.htm

Here is the full text:

FDA Suspends Temporary Emergency Permit of Pet Food Maker

June 12, 2009

The U.S. Food and Drug Administration announced today it was suspending the

temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc.

Evanger's, operating in Wheeling, Illinois, deviated from the prescribed

process, equipment, product shipment, and recordkeeping requirements in the

production of the company's thermally processed low acid canned food (LACF)

products. The deviations in their processes and documentation could result

in under-processed pet foods, which can allow the survival and growth of

Clostridium botulinum (C. botulinum), a bacterium that causes botulism in

some animals as well as in humans.

In April 2008, Evanger’s was issued an “Order of Need for Emergency Permit”

after the agency determined that the company had failed to meet the

regulatory requirements to process a product that does not present a health

risk. In June, 2008, FDA issued Evanger’s a temporary Emergency Permit.

During inspections conducted between March 2009 and April 2009, FDA

determined Evanger’s was not operating in compliance with the mandatory

requirements and conditions of the Temporary Emergency Permit.

“The FDA is stopping Evanger's ability to ship pet food in interstate

commerce,” said Dr. Bernadette Dunham. “Today’s enforcement action sends a

strong message to manufacturers of pet food that we will take whatever

action necessary to keep unsafe products from reaching consumers.”

In order for Evanger's to resume shipping in interstate commerce, the

company must document that corrective actions and processing procedures have

been implemented to ensure that the finished product will not present a

health hazard.

Botulism is a powerful toxin that affects the nervous system and can be

fatal. The disease has been documented in dogs and cats. Signs of botulism

in animals are progressive muscle paralysis, disturbed vision, difficulty in

chewing and swallowing, and progressive weakness to the body. Death is

usually due to paralysis of the heart or the muscles used in breathing.

While FDA’s Center for Food Safety and Applied Nutrition is responsible for

regulating all human and animal LACF processing, FDA's Center for Veterinary

Medicine has authority over animal feed and foods. The two centers are

collaborating on this enforcement action.

06-12-2009, 07:55 PM	#1
dwerten BANNED! Join Date: May 2007 Location: USA Posts: 11,073	Fda suspends evangers permit http://www.fda.gov/AnimalVeterinary/.../ucm166265.htm Here is the full text: FDA Suspends Temporary Emergency Permit of Pet Food Maker June 12, 2009 The U.S. Food and Drug Administration announced today it was suspending the temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc. Evanger's, operating in Wheeling, Illinois, deviated from the prescribed process, equipment, product shipment, and recordkeeping requirements in the production of the company's thermally processed low acid canned food (LACF) products. The deviations in their processes and documentation could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans. In April 2008, Evanger’s was issued an “Order of Need for Emergency Permit” after the agency determined that the company had failed to meet the regulatory requirements to process a product that does not present a health risk. In June, 2008, FDA issued Evanger’s a temporary Emergency Permit. During inspections conducted between March 2009 and April 2009, FDA determined Evanger’s was not operating in compliance with the mandatory requirements and conditions of the Temporary Emergency Permit. “The FDA is stopping Evanger's ability to ship pet food in interstate commerce,” said Dr. Bernadette Dunham. “Today’s enforcement action sends a strong message to manufacturers of pet food that we will take whatever action necessary to keep unsafe products from reaching consumers.” In order for Evanger's to resume shipping in interstate commerce, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard. Botulism is a powerful toxin that affects the nervous system and can be fatal. The disease has been documented in dogs and cats. Signs of botulism in animals are progressive muscle paralysis, disturbed vision, difficulty in chewing and swallowing, and progressive weakness to the body. Death is usually due to paralysis of the heart or the muscles used in breathing. While FDA’s Center for Food Safety and Applied Nutrition is responsible for regulating all human and animal LACF processing, FDA's Center for Veterinary Medicine has authority over animal feed and foods. The two centers are collaborating on this enforcement action.