Ferry Brothers Partnership 2/20/13
| || |
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
CMS # 393020
VIA UPS Next Day Air
February 20, 2013
Mr. Matthew Ferry
Ferry Brothers Partnership
185 Narrow Avenue
Westport, MA 02790
Dear Mr. Ferry:
On November 14 through December 6, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 185 Narrow Avenue, Westport, MA. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the 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 an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the 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 Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about May 2, 2012, you sold a cow, previously identified with an ear tag (b)(4), for slaughter as food. On or about May 2, 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 the following drug residues.
FDA has established tolerances for the above drug residues in the tissues and muscles of cattle as codified in Title 21, Code of Federal Regulations. The presence of these drugs in edible tissue 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).
Our investigation also found 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. For example, you failed to maintain drug treatment and drug inventory records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C 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 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 Karen Archdeacon, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have any questions about this letter, please contact Compliance Officer Karen Archdeacon at (781) 587-7491 or Email at firstname.lastname@example.org.
Amber G. Wardwell
Acting District Director
New England District
USDA/FSIS District Office
Philadelphia, District 60
Mellon Independence Center
701 Market Street 2-B South
Philadelphia, PA 19106
MA Department of Agricultural Resources
251 Causeway Street,
Boston, MA 02114