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U.S. Department of Health and Human Services

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Enforcement Actions

John and Maria Nunes Dairy 09-Apr-08

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

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda CA 94502-7070
Telephone 510/337-6700


April 9, 2008

VIA FEDERAL EXPRESS

Our Reference: 1000307221

John Nunes Sr., Co-owner
Maria Nunes, Co-owner
John and Maria Nunes Dairy
1318 South Washington Road
Turlock, California 95380

WARNING LETTER

Dear Mr. and Mrs. Nunes:

An inspection of your dairy operation located at 1318 South Washington Road, Turlock, California, conducted by a representative of the U.S. Food and Drug Administration (FDA) on January 7, 11, and 14, 2008, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(ii) and 21 U.S.C.§ 342(a)(4)]. Furthermore , the inspection revealed that you provided a false guaranty, a prohibited act under section 301(h) of the Act [21 U.S. C. § 331(h)]. The inspection also revealed that you caused the new animal drugs [redacted] brand Legacy Gentamicin Sulfate Solution [redacted] brand Duramycin 100 Oxytetracycline Hydrochloride Injection, [redacted] Sulfadimethoxine Injection 40%, [redacted] brand Albon Sulfadimethoxine Boluses, and [redacted] brand PEN-AQUEOUS Penicillin G Procaine, Injectable Suspension U.S.P. to become unsafe within the meaning of section 512(a) of the Act [2I U.S.C. § 360b(a)1 and adulterated within the meaning of section 541(a)(5) of the Act [21 U.S.C. § 351 (a)(5)].

You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On or about August 14, 2007, you consigned a dairy cow, identified with back tag number [redacted] for slaughter as food at [redacted]. On or about August 14, 2007, this animal was slaughtered at [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of gentamicin in the kidney. No tolerance has been established for residues of gentamicin sulfate in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.300 (2l C.F.R. 556.300). The presence of this drug in edible tissue from this animal 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazard residues of drugs from edible tissues. 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)].

Furthermore, on or about August 14, 2007, you provided [redacted] with a signed certification, which states that you will not supply [redacted] with any livestock that contain illegal levels of drug residues. On August 14, 2407, you consigned to [redacted] a dairy cow containing illegal levels of gentamicin residues, Providing such a false guaranty is a prohibited act under section 301(h) of the Act [21 U.S.C. § 33I(h)].

In addition, you adulterated the new animal drugs, [redacted] brand Legacy Gentamicin Sulfate Solution, [redacted] brand Duramycin 100 Oxytetracycline Hydrochloride Injection, [redacted] Sulfadimethoxine Injection 40%, [redacted] brand Albon Sulfadimethoxine Boluses, and [redacted] brand PEN-AQUEOUS Penicillin G Procaine, Injectable Suspension U.S.P., within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use the drugs in, conformance with their approved labeling. "Extralabel use, i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if: (1) the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship; and (2) the extralabel use complies with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. § 3606(a)(4) and 21 U.S.C. § 360b(a)(5)], and 21 C.F.R. Part 530. Our investigation found that your extralabel use of these new animal drugs failed to comply with these requirements.

For example, you admitted that in the past you administered [redacted] brand Legacy Gentamicin Sulfate Solution to treat [redacted] in calves, although we acknowledge your statement that you stopped this practice after receiving a letter from USDA concerning the illegal gentamicin residue. Gentamicin is not approved for treating [redacted] in calves. In addition, you admitted that you routinely administer the drugs [redacted] brand Duramycin 100 Oxytetracycline Hydrochloride Injection, and [redacted] Sulfadimethoxine Injection 40%, intravenously, to cows to treat [redacted]. These drugs are not approved to treat [redacted]. In addition, you admitted that you routinely administer four (4) 15-gram boluses of Albon Sulfadimethoxine Boluses to treat cows that have [redacted]. This administration of Albon boluses is at a higher than approved dosage. Finally, you admitted to treating cows for [redacted] with Penicillin G Procaine, injecting 50 cc's into two injection sites (25 cc's per injection site). Your veterinarian has prescribed the extralabel use of Penicillin G, Procaine to treat bacterial infections, but limits that treatment to no more than 15 cc's per injection site.

The above extralabel uses were not done under the supervision of a licensed veterinarian, or in compliance with an extralabel prescription by a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition, your extralabel use of gentamicin resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Furthermore, the extralabel use of sulfadimethoxine in lactating dairy cows is specifically prohibited by 21 C.F.R. 530.41(a)(9). Because your extralabel uses of these drugs were not in compliance with 21 C.F.R. Part 530, the drugs were unsafe under section 512(a) of the Act [2l U.S.C. § 360b(a)] and your use caused the drugs to be 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 specified in this letter and to establish procedures whereby such 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 specified violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, 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 corrective actions have been made.

Your written response should be sent to Karen L. Robles, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Ms. Karen Robles at (916) 930-3674, Ext. 114.

Sincerely,

/S/

Barbara J. Cassens
District Director
San Francisco District