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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pacheco & Fagundes Dairy 10/17/12

  

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

Public Health Service
Food and Drug Administration
 
San Francisco District
Pacific Region
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone:    510-337-6700
FAX:            510-337-6701 

 

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Our Reference: 1000307223
            WARNING LETTER
October 17, 2012
Manuel P. Fagundes, Co-owner
Pacheco & Fagundes Dairy
23328 Road 180
Lindsay, California 93247-9766
 
Rolland Pacheco, Co-owner
Pacheco & Fagundes Dairy
23310 Road 180
Lindsay, California 93247-9766
 
Douglas N. Fagundes, Manager
Pacheco & Fagundes Dairy
23388 Road 180
Lindsay, California 93247-9766
 
Dear Messrs Fagundes and Mr. Pacheco:
 
On June 13, 14, 28 and July 10, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 23388 Road 180, Lindsay, California. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the 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 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 Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the 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 May 3, 2012, you sold a cow (ear tag (b)(4), brucellosis ear tag (b)(4) for human consumption. On or about May 3, 2012, this cow was subsequently identified with back tag (b)(4) and slaughtered by (b)(4). 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 at 9.19 parts per million (ppm) in the kidney tissue. The tolerance for desfuroylceftiofur (marker residue) in the kidney tissue of cattle is .4 ppm as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113. The presence of this drug in edible tissue from this animal at the reported level causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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 Act, 21 U.S.C. § 342(a)(4).
 
We found that you adulterated the new animal drugs ceftiofur hydrochloride sterile suspension, (b)(4), oxytetracycline hydrochloride injection (b)(4), cephapirin sodium (b)(4), and penicillin G procaine injectable suspension (b)(4). Specifically, our investigation revealed that you did not use ceftiofur hydrochloride sterile suspension, oxytetracycline hydrochloride injection, cephapirin sodium, and penicillin G procaine injectable suspension as directed by their approved labeling.  Use of these drugs in this manner is an extralabel use.  See 21 C.F.R. 530.3(a). We have enclosed a copy of 21 CFR Part 530 for your reference.
 
The extralabel use of approved veterinary or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and the implementing regulations at 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 ceftiofur hydrochloride (b)(4), to one of your lactating dairy cows identified with ear tag (b)(4), brucellosis ear tag (b)(4), without following the withdrawal period as stated in the approved labeling. Your extralabel use of ceftiofur hydrochloride was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a), and your extralabel use of ceftiofur resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).
 
We found that you administered oxytetracycline hydrochloride injection (b)(4), to your dairy cows without following the animal class, route of administration, and indications for use as stated in the approved labeling. Your extralabel use of oxytetracycline hydrochloride injection was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
 
We found that you administered cephapirin sodium (b)(4), to your dairy cows without following the dose and frequency of treatment as stated in the approved labeling. Your extralabel use of cephapirin sodium was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
 
We also found that you administered penicillin G procaine injectable suspension (b)(4), to your dairy cows without following the indications for use, dose, and dosage amount per injection site as stated in the approved labeling.  Your extralabel use of penicillin G procaine injectable suspension 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 was 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 Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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.
 
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.
 
 
Sincerely, 
/S/
Barbara J. Cassens
District Director
San Francisco District
U. S. Food and Drug Administration