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Public Health Service Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
May 5, 2011
RETURN RECEIPT REQUESTED
Ms. Holly N. Sher, President
Mr. Joel A. Sher, Vice President
Evanger’s Dog & Cat Food Company, Inc.
221 Wheeling Road
Wheeling, Illinois 60090
Dear Mr. and Ms. Sher:
From December 2, 2010 through February 10, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned food manufacturing facility located at 221 Wheeling Road, Wheeling, Illinois. In addition, on August 19, 2010, FDA received samples of (b)(4) Lamb and Rice Dog Food from the distributor, (b)(4). This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our inspection and from the samples we received from the distributor. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at http://www.fda.gov/1.
We found that you offered for sale (b)(4) Lamb and Rice Dog Food which was adulterated. Under Section 402(b)(2) of the FD&C Act, 21 U.S.C. § 342(b)(2), a food is deemed to be adulterated if any substance has been substituted wholly or in part therefore. Our analytical sample results of this product revealed that a substance (lamb) was not detected in the product and another ingredient (bovine material) detected in the product was substituted therefore. Furthermore, this product was misbranded. Under Section 403(b) of the FD&C Act, 21 U.S.C. § 343(b), a food is deemed to be misbranded if it is offered for sale under the name of another food. This product was offered for sale under the name of “(b)(4) Lamb and Rice Dog Food.” However, the analytical sample results did not detect the presence of lamb, but detected the presence of bovine material.
On December 14, 2010, FDA collected samples of your Evanger’s Grain-free Duck Pet Food during the inspection of your facility. We found that the Evanger’s Grain-free Duck Pet Food product was adulterated. Under Section 402(b)(1) of the FD&C Act, 21 U.S.C. § 342(b)(1), a food is deemed to be adulterated if any valuable constituent has been in whole or in part omitted or abstracted therefrom. Our investigation revealed that a valuable constituent (duck) was not detected in the product and had been omitted or abstracted therefrom. Furthermore, this product was misbranded. Under Section 403(a)(1) of the FD&C Act, 21 U.S.C. § 343(a)(1), a food is deemed to be misbranded if its labeling is false or misleading in any particular. The labeling indicates that Evanger’s Grain-free Duck Pet Food contains duck, but the analytical sample results did not detect the presence of duck in the product.
In addition, your firm was not able to provide processing and production records upon written demand, as required by 21 C.F.R. 108.35(h), for products manufactured in 2009.
The above is not intended to be an all-inclusive list of violations. As a processor of animal food, you are responsible for ensuring that your overall operation and the food you distribute are in compliance with the law. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Rosemary Sexton, Compliance Officer, U.S. Food and Drug Administration, 550 West Jackson Boulevard, Suite 15, Chicago, Illinois 60661. If you have any questions about this letter, please contact Compliance Officer Rosemary Sexton at 312-596-4225.
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