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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ramona Farms 02/09/2009

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


February 9, 2009

2009-DAL-WL-06

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

John Spyksma, Co-owner
Ramona Farms
2451 Ramona Expressway
San Jacinto, California 92582

Dear Mr. Spyksma:

On November 4, 5, and 7, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation, Evergreen Farms, located at 2765 FM 303, Muleshoe, Texas. 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 the 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 July 3, 2008, you sold a dairy cow, identified with back tag [(b)(4)] and ear tag [(b)(4)], for slaughter as food. On or about July 5, 2008, [(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 penicillin at 0.15 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations. Section 556.510 (21 C.F.R. 556.510). The presence of this drug in edible tissue from this animal in this amount 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 and segregate treated animals. 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 also found that you adulterated the new animal drugs [(b)(4)] (Penicillin [(b)(4)] Injection, NADA [(b)(4)] Injection, NADA [(b)(4)] and Furosemide Infection, NADA [(b)(4)]. Specifically, our investigation revealed that you did not use [(b)(4)] Penicillin [(b)(4)] Injection, NADA [(b)(4)] Injection, NADA [(b)(4)] and Furosemide Injection. NADA [(b)(4)] as directed by their approved labeling. Use of these drugs in this manner is an extralabel use 21 C.F.R. 530.3(a).

The extralabel use of approved animal 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 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)] (Penicillin [(b)(4)] Injection, NADA [(b)(4)] to a dairy cow without following the dose as stated in the approved labeling. Your extralabel use of [(b)(4)] (Penicillin [(b)(4)] injection, NADA [(b)(4)] was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and our extralabel use of [(b)(4)](Penicillin [(b)(4)] Injection, NADA [(b)(4)] resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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).

In addition, our investigation found that you administer [(b)(4)] Injection, NADA [(b)(4)] and Furosemide Injection, NADA [(b)(4)] to your dairy cattle without following the animal class as stated in the approved labeling. Your extralabel use of [(b)(4)] Injection, NADA [(b)(4)] and Furosemide Injection, NADA [(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 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 Sherrie L. Krolczyk, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204-3128. If you have any questions about this letter, please contact Compliance Officer Sherrie L. Krolczyk at 214-253-5312.

Sincerely yours,

/S/

Reynaldo R. Rodriguez, Jr.
Dallas District Director

RRR:slk

cc: Chad Spyksma, Co-Owner
Ramona Farms
2451 Ramona Expressway
San Jacinto, California 92582

Hans Van Ruiten, Manager
Evergreen Farms
2765 FM 303
Muleshoe, Texas 79347