Inspections, Compliance, Enforcement, and Criminal Investigations

Hardy Animal Nutrition LLC 2/4/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Cincinnati District Office  
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761

 

February 4, 2016
Warning Letter
CIN-16-482353-
 
VIA UPS OVERNIGHT DELIVERY
 
Eric E. Lofquist, President and CEO
Hardy Animal Nutrition, LLC
679 Hardy Road
Painesville, OH 44077
 
Dear Mr. Lofquist:
 
Investigators from the Food and Drug Administration (FDA) conducted an inspection of your animal food ingredient manufacturing facility located at 679 Hardy Road, Painesville, Ohio from September 22 through October 7, 2015. Our inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), causing the animal food distributed by your firm to be adulterated according to sections 402 (a)(2)(c) and (a)(3) of the FD&C Act [21 U.S.C. §342(a)(3)]. The introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded is prohibited according to section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].  You can find the FD&C Act and its implementing regulations through links on FDA’s web page at http://www.fda.gov.
 
The processes and inclusion of specific ingredients used at your firm cause feed being manufactured and delivered to be adultered under section 402(a)(3) of the FD&C Act [21 U.S.C. §342 (a)(3)]. Specifically,
  • On August 17, 2015, you received a shipment of Brown Grease from (b)(4). The Bill of Lading describes the product as Industrial Grade and contains warning statement DO NOT FEED TO ANIMALS. You stated in a signed affidavit this product was off-loaded into your facility and you processed this into Energy Booster 100, a dried dairy feed ingredient, lot #082015-34 that you subsequently sold as animal feed to (b)(4) 
  • On August 19, 2015, you received a shipment of material identified in labeling as Vegetable Fatty Acid with Pesticides from (b)(4). The invoice contains a pesticide clause stating the material is not intended or suitable for human or animal consumption and certifies that the product will not be used for such purposes. You stated in a signed affidavit, this product was off-loaded into your facility and you processed this into Dairy Feed 165 a liquid dairy feed ingredient, lot numbers 082018-30 and 082015-31, that you subsequently sold as animal feed and shipped to (b)(4).
  • On August 21, 2015, you received a shipment of Sludge Oil from (b)(4). The Bill of Lading identifies the product as Non-Edible Vegetable Oil. You stated in a signed affidavit this product was off-loaded into your facility and you processed this into HLAD, a liquid animal feed ingredient, lot # 151006-88 that you subsequently sold as animal feed to (b)(4) .
Incoming shipment records for the Brown Grease,(invoice # 4391) Vegetable Fatty Acid with Pesticides (order # 3919) and Sludge Oil (invoice #390551), have statements indicating that these products are not intended to be used in animal food; therefore, they are unfit for animal food and are adulterated under 402(a)(3) of the FD&C Act [21 U.S.C. § 342(a)(3)]. Additionally, your Energy Booster 100, Dairy Feed 165 and HLAD animal food products are also adulterated under 402(a)(3) of the FD&C Act [21 U.S.C. § 342(a)(3)] because they contain ingredients that are unfit for food.
 
In addition, the Brown Grease, Vegetable Fatty Acid with Pesticides and Sludge Oil are food additives according to section 201(s) of the FD&C Act [21 U.S. C. 321(s)] because you processed them into products that become components of animal food.   These products are not the subject of any food additive regulations that prescribe the conditions under which they may be safely used. Furthermore, we are not aware of any basis to conclude that these products are generally recognized as safe for use in animal food. The products contain statements indicating that they are not to be used in food; therefore, the Brown Grease, Vegetable Fatty Acid with Pesticide and Sludge Oil are not intended for use as animal food; therefore, they are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)] because they are food additives that are unsafe within the meaning of section 409 of the FD&C Act [21 U.S.C. § 348].
 
The processes used by your establishment of (b)(4) have not been validated or approved to remove contaminates from the animal food ingredients. The products undergoing these processes continue to be used as an animal food ingredient. Using these products in the manufacturing of Energy Booster 100, Dairy Feed 165 and HLAD means that these products are also adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)] because they contain food additives that are unsafe within the meaning of section 409 of the FD&C Act [21 U.S.C. § 348].
 
The above is not intended to be an all-inclusive list of violations.  You are responsible for assuring that your overall operation and any products you distribute comply 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 enforcement actionsuch as seizure and/or injunction without further notice.
 
You should notify this office in writing of the steps 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 taken or that 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 period within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
Section 743 of the Act (21 U.S.C. 379 j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379 j-31(a)(2)(B)].   For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at 513-679-2700, ext. 2163 or stephen.rabe@fda.hhs.gov
 
Sincerely yours,
/S/ 
Steven B. Barber
District Director
Cincinnati District

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