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U.S. Department of Health and Human Services

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Enforcement Actions

Fieser Dairy, Inc. 2/7/12

  

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: 407-475-477
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-12-23

February 7, 2012

Mr. Gerald W. Fieser, President and Co-Owner
Mr. Karl D. Fieser, Vice-President and Co-Owner
Fieser Dairy, Inc.
P.O. Box 278
De Leon Springs, Florida 32130-3538

Dear Sirs:

On November 16 and 17, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5886 Lake Winona Road, De Leon Springs, 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 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 August 15, 2011, you sold two dairy cows, respectively identified with ear tag (b)(4) (USDA Retain Tag (b)(4)) and ear tag (b)(4) (USDA Retain Tag (b)(4)), for slaughter as food. On or about August 16, 2011, (b)(4), slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal with ear tag (b)(4) identified the presence of sulfamethazine at 0.134 parts per million (ppm) in the liver tissue and at 0.063 ppm in the muscle tissue. USDA/FSIS analysis of tissue samples collected from the animal with ear tag (b)(4) identified the presence of sulfamethazine at 0.245 ppm in the liver tissue and at 0.076 ppm in the muscle tissue. FDA has not established a tolerance for residues of sulfamethazine in the edible tissues of lactating dairy cattle. The presence of this drug in the edible tissue from these animals 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 (b)(4), chlortetracycline plus sulfamethazine, (b)(4) Medicated Feed and (b)(4) BRAND MEDICATED Feed (containing decoquinate). Specifically, our investigation revealed that you did not use (b)(4), chlortetracycline plus sulfamethazine, (b)(4) Medicated Feed and (b)(4) BRAND MEDICATED Feed (containing decoquinate) as directed by their approved labeling. Use of these drugs in this manner is an extra-label use. See Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a), 21 C.F.R. Part 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 (b)(4), chlortetracycline plus sulfamethazine, (b)(4) Medicated Feed and (b)(4) BRAND MEDICATED Feed (containing decoquinate) in an unapproved combination of drugs in animal feeds to two dairy cows, respectively identified with ear tag (b)(4) (USDA Retain Tag (b)(4)) and ear tag (b)(4) (USDA Retain Tag (b)(4)), without following the duration of treatment, withdrawal period, and animal class as stated in their approved labeling. Your extralabel use of chlortetracycline was in or on feed, in violation of 21 C.F.R. 530.11(b), your extralabel use of the combination of chlortetracycline and sulfamethazine in animal feed is not approved for use in lactating dairy cattle under 21 C.F.R. 558.140, your extralabel use of decoquinate was in or on feed, in violation of 21 C.F.R. 530.11(b), your extralabel use of decoquinate in animal feed is not approved for use in cows producing milk for food under 21 C.F.R. 558.195, and sulfamethazine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9) and your extralabel use of sulfamethazine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). 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).

In addition, you adulterated both (b)(4), chlortetracycline plus sulfamethazine, (b)(4) Medicated Feed and (b)(4) BRAND MEDICATED Feed (containing decoquinate) within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you fed the unapproved combination of these two medicated animal feeds to your dairy cows. Your feeding of these medicated feeds in this manner and not as directed by the approved labeling of (b)(4), chlortetracycline plus sulfamethazine, (b)(4) Medicated Feed and (b)(4) BRAND MEDICATED Feed (containing decoquinate) caused these medicated feeds to be unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b.  Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.

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.

Your firm’s response, postmarked December 5, 2011, is not adequate. You stated that you will temporarily discontinue use of the medicated feed containing the sulfonamide drug, but as of January 9, 2012, you have not communicated to FDA your final action on this matter. Also, your response does not specifically address extra-label use of this medicated feed and unapproved combinations of drugs used in or on feed administered to the calves raised at your firm as replacement animals for your dairy cattle.  Further, the records you included with your response show that your treatment records continue to be inadequate in that they do not include the dose administered.

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 Ronnie E. Jackson, Director, Compliance Branch, U.S. Food and Drug Administration, Florida District, at 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions about this letter, please contact Mr. Jackson by telephone (407) 475-4734 or via e-mail at ronnie.jackson@fda.hhs.gov.

Sincerely,

/s/

Emma R. Singleton
Director, Florida District