Wilton Black 2/28/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
AMENDED WARNING LETTER
CMS # 419585
VIA UPS Next Day Air
February 28, 2014
Wilton Black, Owner
2040 Hallowell Rd
Litchfield, ME 04350
Dear Mr. Black,
An inspection of your operation located in Litchfield, ME by a Food and Drug Administration (FDA) investigator on December 19, 2013 and January 8, 2014 confirmed a bob veal calf with ear tag (b)(4) purchased, hauled, and sold by you to (b)(4) on February 5, 2013, was in violation of Section 402 (a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act). On February 7, 2013, this calf was slaughtered in New York and United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of flunixin in the kidney tissue. FDA has not established a tolerance for residues of flunixin in the edible tissues of preruminating calves. The presence of this drug in edible tissues from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).
You should take prompt action to correct the above 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 seizure and/or injunction. The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animal. As such, you share the responsibility for violating the Federal Food, Drug and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:
1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal;
2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and
3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue.
If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.
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 the Food and Drug Administration, Attention: Scott M. Loughan, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4725 x 109.
Miguel A. Hernandez
Acting District Director
New England District