Inspections, Compliance, Enforcement, and Criminal Investigations
Mary Borba Parente dba: L&M Dairy 12/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
December 10, 2012
Mary B. Parente, Owner
8559 Edison Avenue
Ontario, California 91762-7247
Dear Ms. Parente:
On August 13, September 27, and October 5, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8559 Edison Avenue, Ontario, California 91762-7247. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.
We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b.
Specifically, sometime between late May and early June, 2012, nine heifer calves were removed from (b)(4). The L&M Dairy calves located at (b)(4) were being raised as herd replacement animals, to be returned to the L&M Dairy at approximately 120-150 days of age. Of the nine animals picked up and transported to the (b)(4) L&M Dairy acknowledged that two of the non-formula fed calves identified with back tag (BT) (b)(4)(ear tag (b)(4)) and BT (b)(4)(ear tag (b)(4)) were from their dairy herd according to their records. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of neomycin at 11.36 parts per million (ppm) and 10.69 ppm in the kidney tissue respectively. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430 (21 C.F.R. 556.430). Therefore, the presence of this drug in edible tissue from these animals in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is 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 Blake Bevill, Director, Compliance Branch, U.S. Food and Drug Administration, Los Angeles District, at 19701 Fairchild, Irvine, California 92612. If you have any questions about this letter, please contact Compliance Officer William S. Vitale at (949) 608-2919 or via e-mail at William.Vitale@fda.hhs.gov.
Alonza E. Cruse, Director
Los Angeles District
Ms. Ingeborg Small, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, California 95899-7435