Inspections, Compliance, Enforcement, and Criminal Investigations

Pleasant Valley Farms of Berkshire, LLC 8/21/15

  

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 # 476784
 
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
 
August 21, 2015
 
 
Mark St. Pierre, Co-Owner
Amanda St. Pierre, Co-Owner
Pleasant Valley Farms of Berkshire, LLC
1546 Richford Road
Richford, VT 05476
 
 
Dear Mr. & Mrs. St. Pierre:
 
On June 15, 2015, June 23, 2015, and July 15, 2015 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3082 VT Route 105, East Berkshire, VT 05447. 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 an animal for slaughter as food that was 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. Further, under section 402(a)(4) of the FD&C 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 October 20, 2014, you sold a dairy cow, identified with farm ear tag # (b)(4), State ear tag # (b)(4), and State back tag # (b)(4) for slaughter as food. On or about October 21, 2015 (b)(4), slaughtered this animal for human food. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of ampicillin at 0.2 ppm in the kidney tissue. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the edible tissues of cattle, as codified at 21 C.F.R. 556.40. 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 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 complete treatment records and you failed to systematically review existing treatment records prior to offering a treated animal for slaughter as human food. 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.
 
We received your written response dated July 22, 2015, from Ms. Amada St. Pierre, Co-Owner, which included a letter describing your firm’s corrections to the FDA-483 observations. Your response is not adequate since your previous promises of corrections as stated by you during a regulatory meeting held with your firm on May 29, 2014 were either not implemented or were not effective and you have not provided any additional clarification about how your corrective actions will now be fully implemented and effective at ensuring the animals you ship to slaughter for human food are free from illegal drug residues.
 
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 Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions about this letter, please contact Mr. Loughan at (802) 868-4725 X 109 or email at Scott.Loughan@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Amber G. Wardwell
Acting District Director
New England District

Page Last Updated: 08/25/2015
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