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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Moniz Dairy Farm 3/16/12

  

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

Public Health Service
Food and Drug Administration
 
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
Phone: (781) 587-7500 
FAX: (781) 587-7556 

 

WARNING LETTER
CMS # 282939
                                                                    
VIA OVERNIGHT UPS
 
March 16, 2012
 
Mrs. Georgianna J. Moniz, Co-Owner
Moniz Dairy Farm
408 Stafford Road
Tiverton, Rhode Island 02878
 
Dear Mrs. Moniz:
 
On December 19, 2011 and January 31, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 454 Stafford Road, Tiverton, Rhode Island 02878. 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 July 12, 2011, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 13, 2011, (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 0.4 parts per million (ppm) of penicillin in the kidney tissue, and 83.202 ppm of sulfamethazine in the liver tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues in cattle as codified in Title 21, Code of Federal Regulations, Section 556.510(a) (21 C.F.R. 556.510(a)) and 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues in cattle in 21 C.F.R. 556.670. The presence of these drugs in edible tissue from this animal in these amounts 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. 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).
 
We also found that you adulterated the new animal drug (b)(4). Specifically, our investigation revealed that you did not use Agri-Cillin as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 
 
Our investigation found that you administered penicillin in a class of animal, veal calf, not set forth in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use penicillin resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
 
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. 
 
Our investigation also revealed that on or about May 1, 2003, you provided (b)(4) with a signed Livestock Owner’s Certificate (continuing) certifying that, among other things, none of the livestock shipped or delivered to the auction will have an illegal level of drug residues. This signed certificate covers the bob veal calf identified with back tag (b)(4), which was found to have violative penicillin and sulfamethazine residues. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur. 
 
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 Todd Maushart, Compliance Officer, U.S. Food and Drug Administration, 200 Seaport Blvd., Suite 125, Boston, Massachusetts 02210. If you have any questions about this letter, please contact Compliance Officer Todd Maushart at (617) 428-4996, extension 114 or Email at todd.maushart@fda.hhs.gov.
 
Sincerely yours,
/S/
Mutahar S. Shamsi
District Director
New England District
 
     
 
cc:    
Mr. Antone G. Moniz, Sr., Co-Owner
Moniz Dairy Farm
408 Stafford Road
Tiverton, Rhode Island 02878
           
Mr. Joseph S. Moniz
Farm Manager
Moniz Dairy Farm
408 Stafford Road
Tiverton, RI 02878
 
Haroon Mian
USDA/FSIS District Office
District 65
230 Washington Ave.
Albany, NY 12203