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Evanger’s escalates war of words, challenges FDA investigation

Friday, March 3, 2017 23:03
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(Before It's News)

A family-owned pet food company under investigation after a euthanasia drug was found in its canned dog food has taken its dispute with the FDA to the public.

On March 2, FDA reported on its website that, based on a preliminary assessment, none of Evanger’s Dog & Cat Food suppliers were USDA-FSIS registered facilities.

In response, the Wheeling, Il, company owned by Holly and Joel Sher posted the following notice on its website:

“The FDA recently stated it believes that Evanger’s does not purchase any edible beef, yet in its investigation never asked a simple question, ‘does Evanger’s purchase edible beef.’ Evangers does, in fact, purchase edible beef, and did purchase edible beef around the same time as the recalled beef was supplied.

“Our intention was not to start an online war with the FDA, but the FDA has taken unprecedented actions specifically against Evanger’s. We will continue to post information in regards to FDA’s recent actions, but meanwhile are sharing this with our loyal customers now.”

“This” refers to a redacted invoice dated July 14, 2016, that shows the delivery of a shipment of edible beef bones, frozen organic beef product and edible beef livers to Evanger’s.

The Evanger’s statement replaced all previous website communications from the company to its customers on the subject of its dog food recalls due to contamination with pentobarbital. Several dogs have become ill and at least one died after eating the dog food that was later recalled.

The latest salvo in an ongoing effort by Evanger’s to challenge some components of the Inspectional Observations Form 483 report issued on Feb. 14 at the conclusion of Food and Drug Administration inspections of the company’s Wheeling and Markham production facilities.

It is standard operating procedure for FDA inspectors to present to the “highest management official available” a completed Form 483 immediately on the completion of an inspection and before leaving the premises. It is not uncommon for management or owners of a facility to respond in writing to the observations listed on a Form 483.

An FDA spokesperson has confirmed that the agency has received and is reviewing Evanger’s response to the Inspectional Observations Form 483 reports for the Wheeling and Markham production facilities.

In addition to its formal reply to FDA, Evanger’s used a Feb. 28 letter to its distributors and retailers to take issue with certain of the observations listed in the Form 483 report for the Wheeling facility.

FDA’s observations
On Jan. 10 and 11, condensate dripped throughout your processing facility from the building framing, ceiling, walls, and from tarps suspended above food processing areas, including condensate dripping directly into open cans of the in-process low-acid canned dog food product Hunk Of Beef, and also into multiple open totes of raw meats including beef intended for your canned dog food product Hunk Of Beef.

The floors throughout your processing facility are pitted, cracked and otherwise damaged causing pooled water in areas where food is exposed including where open cans of in-process Hunk Of Beef dog food are staged on a wooden pallet immediately upon the damaged floor.

Additional sanitary conditions observed on the same dates included peeling paint and mold on walls throughout the processing facility including in areas where food is exposed, a live fly-like insect in the Hunk Of Beef hand-packing area during processing, and an open sanitary sewer within approximately 25 feet of two food storage trailers and one food processing trailer at the rear exterior of the facility.

Evanger’s responses
In some instances the investigators made observations without full knowledge of the operations of the firm, and other observations were made which are not true. An example of an untrue observation is that an inspector saw cracks in our floor. The “cracks” were actually expansion joints that are put into all new floors to prevent cracking.

There was condensation in areas of the plant because the temperature in Chicago was 35 degrees, then jumped to 57 degrees the following day. Since we manufacture using steam, the steam combined with the extreme temperature swing caused condensation. However, no condensation would have or could have entered any of our raw materials or in-process product because all materials are covered and protected at all times.

We use over 20,000 gallons of water per day and water is never stagnant in our facility. Water is frequently used and flowing during cleanup and sanitation procedures which happen throughout the day.

There are no flies in Illinois in winter.

Photographic evidence
Taking photographs during an inspection is standard procedure, according to Chapter 5 of FDA’s Inspections Operations Manual, and could help rectify these competing statements from the company and FDA inspectors. Inspectors are instructed to take a camera “… into the firm and use it as necessary just as you use other inspectional equipment.”

In some cases, company management objects to the taking of photographs. FDA has declined to comment on whether or not inspectors of the Wheeling and Markham facilities were permitted by management to take photographs inside the manufacturing plants during the January inspection.

What’s next?
The investigation is ongoing. According to an agency spokesperson, FDA is investigating all of Evanger’s suppliers of meat, and is following up on four consumer complaints for which veterinary and product identification information are available.

FDA continues to encourage consumers to report problems with Evanger’s products through the Safety Reporting Portal or by contacting a Consumer Complaint Coordinator. Please retain empty cans or partially used cans of food to facilitate collection of specific lot number information. Additional information is available on the FDA web page, How to Report a Pet Food Complaint.

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Source: http://www.foodsafetynews.com/2017/03/evangers-escalates-war-of-words-challenges-fda-investigation/

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