Inspections, Compliance, Enforcement, and Criminal Investigations

Lussier Dairy, Inc. 1/26/15

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
FAX: 407-475-4770


 

VIA USPS PRIORITY MAIL
 
WARNING LETTER
FLA-15-11
January 26, 2015
 
Mr. Matthew S. Lussier, Vice President, Secretary and Treasurer
Mrs. Linda Lussier, President
Lussier Dairy
P.O. Box 2168
Hawthorne, Florida 32640-3418
 
Dear Mr. and Mrs. Lussier:
 
On December 3, 4 and 5, 2014, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 4203 SE US Highway 301 Hawthorne, Florida. This letter notifies you of 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 two animals for slaughter as food that were 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 June 23, 2014, you sold a dairy cow identified with back tag (b)(4) (ear tag (b)(4)) for slaughter as food.  On or about June 27, 2014, (b)(4), Florida 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 (marker residue for ceftiofur) at 8.16 parts per million (ppm) in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)).
 
Our investigation also revealed that on or about July 14, 2014, you sold a dairy cow identified with back tag (b)(4) (ear tag (b)(4)) for slaughter as food.  On or about July 17, 2014, (b)(4) slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of penicillin at 0.239 ppm in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in 21 C.F.R., Section 556.510 (21 C.F.R. 556.510). The presence of these drugs in edible tissues from these animals 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 drugs Bactracillin G (Penicilllin G Procaine, NADA 065-010) and Excede (Ceftiofur Crystalline Free Acid, NADA-141-209). Specifically, our investigation revealed that you did not use Bactracillin G and Excede as directed by their approved labeling or veterinary prescription.  Use of these drugs 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 Bactracillin G to a dairy cow with back tag (b)(4) (ear tag (b)(4)) without following the indications for use and dosage as stated in the approved label. Our investigation also found that you administered Excede to a dairy cow with back tag (b)(4) (ear tag (b)(4)) without following the indications for use and route of administration as stated in the approved label. Your extralabel use of Bactracillin G and Excede was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of Bactracillin and Excede resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Your extralabel use of a cephalosporin (Excede), by an unapproved route of administration, is prohibited by 21 C.F.R. § 530.41(13)(ii). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused these drugs 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).
 
We note your response via email received on December 16, 2014 with a hard copy received in our office on December 30, 2014. All voluntary corrections indicated in your response will be verified at the next scheduled inspection of your farm.
 
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 are in compliance with the law. 
 
You should take prompt action to correct the violations described in this letter and 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 timeframe 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 Carla Norris, Compliance Officer, at the address on this letterhead.  If you have any questions about this letter, please contact Carla Norris at (407)-475-4730.
 
Sincerely,
/S/ 
Susan M. Turcovski
Director, Florida District

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