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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Windy Ridge Dairy 8/19/11

  

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

Public Health Service
Food and Drug Administration
 

Detroit District
300 River Place
Suite 5900
Detroit. MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

WARNING LETTERS
2011-DET-15

VIA UPS

August 19, 2011

Mr. Steven A. Bos, Owner
Windy Ridge Dairy
1652 N 1100 W
Fair Oaks, IN  47943-8552

Dear Mr. Bos:

An inspection of your dairy operation located at 1652 N 1100 W, Fair Oaks, IN 47943 was conducted by a representative of the Food and Drug Administration (FDA) on June 10 through July 21, 2011, and confirmed that you offered a culled dairy cow for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342 (a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342 (a)(4)] of the Food, Drug, and Cosmetic Act (the Act).  You can find the Act and its associated regulations on the Internet through links of the FDA’s web page at www.fda.gov

On August 11, 2010, you sold a culled dairy cow to (b)(4) which was identified with back tag number (b)(4) and with dangle tag number (b)(4).  This animal was slaughtered for human food use on August 11, 2010. The United States Department of Agriculture/Food Safety Inspection Service (USDA/FSIS) analyzed tissue samples collected from this animal and identified the presence of penicillin residue at 1.43 ppm in the kidney. A tolerance of 0.5 has been established for this drug in the uncooked edible tissues of cattle as codified in Title 21 Code of Federal Regulations, Part 556.510 (21 CFR. 556.510). 

Your above actions caused a residue of an approved human or animal drug to occur above an established safe level, safe concentration, or tolerance, through use of the drug contrary to its labeling, and failing to take appropriate measures to assure that assigned timeframes for withdrawal were met and no illegal residue would occur. 

Our investigation has determined that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Your lack of a system to prevent these medicated animals from entering the food supply causes the food from these animals to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342 (a)(4)].

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 these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as a seizure and/or injunction.

You should notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations. 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, 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 response should be directed to Michael V. Owens, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, MI 48207.  If you have any questions about this letter, please contact Compliance Officer Owens at 313-393-8167.

Sincerely,

/s/

                
Glenn T. Bass
District Director
Detroit District Office