Azevedo and Sons Dairy, Inc. 3/4/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421

Telephone: 425-486-8788

FAX: 425-483-4996

 

March 4, 2011

 

CERTIFIED MAIL 

RETURN RECEIPT REQUESTED

 

In reply refer to Warning Letter SEA 11-06

 

Lisuarte M. Azevedo, President

Azevedo and Sons Dairy, Inc.

10034 Hendricks Road

Othello, Washington 99344

 

WARNING LETTER

 

 Dear Mr. Azevedo:

 

On January 5 and 13, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 10034 Hendricks Road, Othello, Washington. 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 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 July 23, 2010, you sold a cow, identified with ear tag number (b)(4) for slaughter as food. On or about July 23, 2010, (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 0.801 parts per million (ppm) flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the edible tissues of cows as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. § 556.286). In addition, our investigation revealed that on or before May 6, 2010, you delivered a cow identified with ear tag number (b)(4) to (b)(4). On or about May 6, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 0.755 ppm sulfadimethoxine in liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cows as codified in 21 C.F.R. § 556.640. The presence of these drugs in edible tissue from these 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 drugs Banamine NADA # 101-479 (flunixin meglumine) and Albon NADA # 031-715 (sulfadimethoxine). Specifically, our investigation revealed that you did not use flunixin meglumine and sulfadimethoxine as directed by their approved labeling. Use of these drugs in this manner is an extralabel use as indicated in 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 flunixin meglumine to the cow identified with ear tag number (b)(4) without following the dose, route of administration, and withdrawal period as stated in the approved labeling. Your extralabel use of flunixin meglumine was not under the supervision of a license veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of flunixin meglumine resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Our investigation also found that you administered sulfadimethoxine (Albon) to the cow identified with ear tag number (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. § 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Because your use of these drugs were not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the 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).

 

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 4, 2010, and on or about August 17, 2010, you provided to (b)(4), a signed certification, that states that all animals brought to (b)(4), for sale or processing, have been handled in a manner to prevent pharmaceutical or biological residue violation. On or about July 23, 2010, you delivered a cow containing violative flunixin residue to (b)(4). 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 Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22201 23^rd Drive SE, Bothell, Washington 98021-4426. If you have any questions about this letter, please contact Compliance Officer Patricia Pinkerton at 425-483-4926.

 

Sincerely yours,

 

S/ 

 

Charles M. Breen

District Director

 

 

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