Da Rosa Dairy 2/25/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 3000207101
February 25, 2013
Olivia Da Rosa, Owner
Da Rosa Dairy
1131 South Story Road
Turlock, California 95380-9121
Dear Mrs. Da Rosa:
On December 11, 12, and 19, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1131 South Story Road, Turlock, California. 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 August 8, 2012, you sold a bob veal (bull) calf, identified with ear tag (b)(4), for slaughter as food. On or about August 8, 2012, (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 neomycin at 38.5 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to the use of (b)(4) (neomycin sulfateandoxytetracycline hydrochloride) in bob veal calves (pre-ruminating calves). There is no acceptable level of residue associated with the use of neomycin sulfate in veal calves. The presence of this drug in edible tissue from this animal in the amount noted above 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) (neomycin sulfate and oxytetracycline hydrochloride) and (b)(4) (oxytetracycline hydrochloride injection) (b)(4). Specifically, our investigation revealed that you did not use (b)(4) and oxytetracyline as directed by their approved labeling. Use of these drugs in this manner is an extralabel use, 21 C.F.R. § 530.3(a). We have enclosed a copy for your reference.
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) (neomycin sulfate and oxytetracycline hydrochloride) to one of your bob veal (bull) calves identified with ear tag (b)(4) without following the animal classas stated in the approved labeling. Your extralabel use of (b)(4) was in or in feeds, in violation of 21 C.F.R. 530.11(b) and your extralabel use of (b)(4) resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). We also found that you administered (b)(4) to your dairy cows without following the animal class, dosage, and conditions of use as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). 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).
In addition, you adulterated (b)(4) within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you failed to use the drug in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe within the meaning of 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.
FDA acknowledges the written response we received following our inspection. A letter dated January 2, 2013, was received addressing the observations made during the inspection we conducted at your location in Turlock, California. Although your letter indicates that your firm has taken steps to address our observations, your response did not contain enough detail for us to evaluate. The corrections your firm has implemented will be evaluated and verified during our next inspection.
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 Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov
Acting District Director
San Francisco District
U. S. Food and Drug Administration