# FDA SUSPENDS EVANGERS PERMIT



## dwerten (Oct 6, 2007)

http://www.fda.gov/AnimalVeterinary/NewsEv...s/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.


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## Furbaby's Mommie (Jul 10, 2004)

Thank goodness I don't use it. Thanks for the post. :bysmilie:


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## CeeCee's Mom (Sep 14, 2006)

Yikes...the person I bought Rain from sent Evangers pet food and I have been mixing it with CeeCee's food to wean her off of it.....it is in the garbage as soon as I type this!!!!!


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## Ladysmom (Oct 19, 2004)

Yikes! I am really glad I have to homecook for Lady. I don't know if any commercial pet food is safe anymore.


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## Toby's Mom (May 7, 2004)

Does it ever stop? :smpullhair: :smpullhair:


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## Purple-peep (May 14, 2009)

Thank you for posting this!

I think the people who make this crap, should be forced to eat it :angry:


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## dwerten (Oct 6, 2007)

lol i strongly agree 


QUOTE (Purple-peep @ Jun 12 2009, 11:50 PM) index.php?act=findpost&pid=790184


> Thank you for posting this!
> 
> I think the people who make this crap, should be forced to eat it :angry:[/B]


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## 3Maltmom (May 23, 2005)

QUOTE (Purple-peep @ Jun 12 2009, 10:50 PM) index.php?act=findpost&pid=790184


> I think the people who make this crap, should be forced to eat it :angry:[/B]



I agree :thumbsup:


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## kathym (Aug 5, 2006)

QUOTE (Purple-peep @ Jun 12 2009, 11:50 PM) index.php?act=findpost&pid=790184


> Thank you for posting this!
> 
> I think the people who make this crap, should be forced to eat it :angry:[/B]



A nice big bowl full!!!


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## Nikki's Mom (Feb 13, 2008)

Oh, sheesh, I keep a case of it for emergencies if I can't home cook for Nikki. It's going in the dumpster. For emergencies, Nikki will get scrambled eggs and canned (people food) chicken or salmon, if I am too sick to cook for her.


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## luvmyfurbaby (Feb 11, 2007)

Just got this in my email.


As you may now be aware, over the weekend the FDA suspended our ability to ship interstate commerce due to our failure to properly document & file our food processing. Below is the explanation of what exactly happened. There is not a problem with the quality of the food. There are NO RECALLS mandatory or voluntary nor were we asked to do so. Please read the information & share it with your retailers. They can post it in their stores. Let me know if I can be of further assistance. Remember to remind retailers that this does not affect our dry or treats product lines.

Thank you for your continued support!
-Carol Siflinger
Evanger's Southeast Territory Manager

June 14, 2009

To All Valued EVANGER'S DOG AND CAT FOOD, INC. Customers,
As you are aware, The F.D.A. has taken action against our company. Although there are no recalls, or any allegations of unsafe foods manufactured by Evanger's, we feel that we must respond to this situation with a detailed report.
The main reason for the suspension of our permits involves confusion while updating the FILED SCHEDULED PROCESSES as required by F.D.A. rules 21 CFR 108.35(2) and 21 CFR 113.83. To elaborate, these rules dictate that all "STYLES" of food must be studied for adequate heat penetration to achieve "commercial sterility". This procedure usually involves the understanding that heat penetrates different consistencies of product at different rates. For example heat penetrates Evanger's 100% ALL MEAT COOKED CHICKEN at a different rate than Evanger's ALL FRESH VEGETARIAN style formula. 

Our "Process Authority" (F.D.A. recognized expert) communicated to the F.D.A. that he intended to file a single SCHEDULED PROCESS that would cover ALL loaf style foods that are manufactured at Evanger's using the "MOST RIGOROUS" process (VEGETARIAN). The intention being, that applying this process to all loaf style products would add an additional layer of safety to all other loaf style products. At the same time our process authority indicated that he would "CLEAN UP" our file by deleting older processes.

In August of 2008, our process authority completed the update of our file.
During a regularly scheduled inspection by the F.D.A we were notified by the inspector that the FILED PROCESSES that we normally use were deleted from our file. Furthermore, the only FILED PROCESS that remained only allowed us to manufacture "VEGETARIAN" foods. To validate this account: we are publishing the actual explanation that was sent to us by the F.D.A. as sighted for the reason for taking action (SEE ATTACHED)

[FDA RESPONSE]
Your firm's processing authority's response stated it had replaced two older filings with a new filing, Submission Identifier (SID) 2008-03-21/003, to cover all variations of "Loaf Style" pet food produced by Evanger's in the 300 x 400 can size including "Vegetarian Style Loaf". However, documentation on all formula types that your firm intended to include under this filing was not provided. Compliance with 21 CFR 108.35©(2) will require your firm to submit a filing for each of the above products, including the ingredients for the various formulations. The additional products that can be called "loafs" using the same process will need their own SID unless they can be included in the existing filing (SID 2008-03-21/003) in which case your processing authority will have to show that these additional products heat the same or faster than the product originally filed as SID 2008-03-21/003 and that the filed minimum scheduled process is sufficient for the safety of all the various product formulations.

Your firm failed to submit to FDA, within 30 days after first use, a complete description of the modification made and utilized and a copy of the file record showing prior substantiation by a qualified scientific authority for the following products as required by 21 CFR 108.35©(2)(ii):

· On 8/12/08, TechniCAL (your contracted process authority) cancelled SID# 1996-03-15/001 and SID# 1977-08-23/001, Loaf Style Dog and Cat Food Ground Meat & Grain Blends in tinplate steel 300 x 405 and 300 x 407 cans, respectively. FDA was not notified of the change from the can size filed to 300 x 400 for Loaf Style Dog and Cat Food Ground Meat & Grain Blends.

The management of EVANGER'S is working closely with the F.D.A and our Process Authority to resolve this matter quickly.

The issue involves only canned food products.

THERE ARE NO RECALLS OR SAFETY ISSUES ASSOCIATED WITH THIS SITUATION. All Evanger's products that are currently on store shelves are safe as they always have been.

Evanger's Dog and Cat Food Co., Inc. continues and will continue to manufacture the highest quality, nutritious, wholesome, innovative and safe pet foods and treats as it has done for over 75 years.

We hope this response addresses the confusion that has been in the marketplace as of recently. For all additional inquiries, please contact EVANGERS DOG AND CAT FOOD CO., INC. at 1800 288-6796.

We thank you for your understanding.

Respectfully,
Joel Sher
Vice President
EVANGERS DOG AND CAT FOOD CO., INC.


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## littlemissy (May 19, 2009)

QUOTE (Purple-peep @ Jun 12 2009, 10:50 PM) index.php?act=findpost&pid=790184


> Thank you for posting this!
> 
> I think the people who make this crap, should be forced to eat it :angry:[/B]


Thank goodness we don't use this brand- it is very frightening. Thank you Spoiled Maltese members for always staying up on the latest news and posting it here. I have lurked long before I joined and this info when it unfortunately comes is always posted here and I thank you for that.


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