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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Milk Flow Dairy 09-Dec-05

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

Public Health Service
Food and Drug Administration

 

Southwest Region
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, CO 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100


December 9, 2005

CERTIFIED MAIL
RETURN RECEIPT RE QUESTED

Calvin W. Pareo
Co-Owner
Milk Flow Dairy
637 South Roosevelt Road #8
Portales, NM 88130

WARNING LETTER
Ref. #: DEN-06-06

Dear Mr. Pareo:

An investigation of your dairy operation conducted by a representative of the U.S. Food and Drug Administration (FDA) on August 8-12, 2005, confirmed that you repeatedly offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342 (a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

During March and April 2005, you consigned for sale four dairy cows for slaughter as food at [redacted]. These animals were slaughtered [redacted]. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of illegal residues of Sulfadimethoxine and Flunixin, as noted in the table that follows:

Back Tag No.

Slaughter Date

USDA Ltr Date

Tissue

Residue

Amount

[redacted]

March 31, 2005

April 20, 2005

Liver

Sulfadimethoxine+

19.40 ppm

Muscle

Sulfadimethoxine+

13.89 ppm

Liver

Flunixin+

.132ppb
(equal to .132 ppm)

[redacted]

April 4, 2005

April 14, 2005

Liver

Sulfadimethoxine+

2.19 ppm

Muscle

Sulfadimethoxine+

1.26 ppm

[redacted]

April 19, 2005

May 3, 2005

Liver

Sulfadimethoxine+

14.76 ppm

Muscle

Sulfadimethoxine+

8.67ppm

Liver

Flunixin+

229 ppb (equal to .229 ppm)

[redacted]

April 19, 2005

May 3, 2005

Liver

Sulfadimethoxine+

12.53 ppm

Muscle

Sulfadimethoxine+

6.14 ppm

Liver

Flunixin+

177 ppb (equal to .177 ppm)

A tolerance of 0.1 parts per million (ppm) has been established for residues of Sulfadimethoxine in the edible tissue of cattle, as codified in Title 21, Code of Federal Regulations (CFR), Section 556.640 (21CFR 556.640). The presence of this drug in the edible tissues of these animals in amounts exceeding the tolerance set out in 21 CFR 556.640 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 tolerance of 125 parts per billion (ppb) and 25 ppb has been established for residues of Flunixin in cattle liver and muscle tissues, respectively, as codified in 21 CFR 556.286. The presence of this drug in the edible tissues of these animals in amounts exceeding the tolerance set out in 21 CFR 556.286 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. As demonstrated in the above table, you lack an adequate system to ensure that animals sold or medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you do not maintain medical treatment records for your animals.

ln addition, you lack :

1. A system that identifies the animals you purchase from individuals or other dealers and that allows you to trace the source of the animals;

2. A system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and

3. If the animal has been medicated, a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues.

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)].

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 foods you distribute are in compliance with the law.

You should take prompt action to correct the above violations 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 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 with your response copies of any documentation demonstrating that corrections have been made.

Your response should be sent to William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Compliance Officer William H. Sherer at (303) 236-3051.

Sincerely,

/S/

B. Belinda Collins
District Director
Denver District