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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Leroy C. Wormell, Jr. and Son, Inc. 7/3/13

  

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

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556 
 
WARNING LETTER
CMS # 405902
 
 
VIA UPS Next Day Air
 
July 3, 2013
 
Leroy C. Wormell, Jr., Owner
Leroy C. Wormell, Jr. and Son, Inc.
184 Brook Street
Westbrook, ME 04092
 
Dear Mr. Wormell:
 
An inspection of your operation located in Cumberland, Maine by a Food and Drug Administration investigator on April 4, 2013 to May 3, 2013 confirmed a dairy cow with back tag (b)(4), ear tag (b)(4) and bangles tag (b)(4) purchased, hauled, and sold by you on or about September 18, 2012, for slaughter for human food to (b)(4) at (b)(4) was in violation of Section 402 (a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act. On or about September 19, 2012, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur at 3.71 parts per million (ppm) in the kidney tissue and flunixin at 0.398 parts per million (ppm) in the liver tissue. FDA has established a tolerance for residues of desfuroylceftiofur at 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113, 21 C.F.R. 556.113 and a tolerance of 0.125 ppm for residues of flunixin in the liver (target tissue) of cattle, as codified at 21 C.F.R. 556.286. The presence of these drugs in the edible tissues from this animal in these amounts cause 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).
 
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.
 
Sincerely,
/S/ 
CAPT Scott J. Lewis, USPHS
Acting District Director
New England District