|Subject:||Illegal Drug Residue|
|Issuer:||New York District Office|
|Issued:||Jan. 30, 2006||Closed:||
Department of Health and Human Services
Public Health Service
158-15 Liberty Avenue
January 30, 2006
WARNIN G LETTER
File No.: NYK 2006-08
RETURN RECEIPT REOUESTED
Darryl T. Murrock, Owner January 30, 2006
24658 State Route 283
Watertown, NY 13601
Dear Mr. Murrock:
On October 28, 31, and November 2, 2005, a U.S. Food and Drug Administration investigator conducted an inspection at your dairy farm located at 24658 State Route 283, Watertown, New York. This inspection confirmed that you offered an animal for sale for slaughter as food that was adulterated within the meaning of 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). The inspection also revealed that you caused the human drug sulfamethoxazole and trimethoprim tablets and the new animal drug ampicillin for injectable suspension to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] and unsafe under section 512 of the Act [21 U.S .C § 360b]. 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 September 12, 2005, you sold a calf identified with tag P658 for slaughter as human food to [redacted] .On or about September 14, 2005 this animal was slaughtered by [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 1.14 and 9.37 parts per million (ppm) sulfamethoxazole in liver tissue and muscle tissue, respectively. Sulfamethoxazole is not approved for use in cattle and no tolerance has been established for residues of sulfamethoxazole in edible tissues of cattle. The extralabel use of sulfamethoxazole, without complying with Section 512(a)(5) of the Act [21 U.S.C. 360b(a)(5)] and the extralabel use regulations in 21 CFR Part 530, causes the drug to be unsafe within the meaning of Section 512 of the Act [21 U.S.C. 360b]. The presence of this unsafe drug in edible tissues 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 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 on your farm 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 treatment records for calves. Food from animals held under such conditions is adulterated under Section 402(a)(4) of the Act [21 U.S .C. § 342(a)(4)].
You adulterated the human drug sulfamethoxazole and trimethoprim tablets within the meaning of section 501(a)(5) of the Act [21 U.S .C. § 351(a)(5)] when you failed to use it in compliance with extralabel use regulations in Title 21, Code of Federal Regulations, Part 530 (21 CFR 530). "Extralabel use," i.e., the actual or intended use of a drug in a manner that is not in accordance with approved labeling is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship . The extralabel use of approved human drugs must comply with section 512(a)(5) of the Act and 21 CFR Part 530. In this instance, you failed to observe the 30 day meat withdrawal time prescribed by your veterinarian and your extralabel use of this drug resulted in the presence of a drug residue in edible tissue that may present a risk to public health, in violation of 21 CFR 530.11(c). Because your extralabel use of this drug was not in compliance with 21 CFR 530 the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].
In addition, you adulterated the animal drug ampicillin for injectable suspension, within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use it in compliance with extralabel use regulations in 21 CFR Part 530. Your use of the drug ampicillin for injectable suspension was contrary to your veterinarian's written order. An employee was observed infusing the drug into the udder of a cow bearing tag # 1076, instead of administering the drug intramuscularly as prescribed. Your use, therefore, was not by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship, in violation of 21 CFR 530.10(a). Because your extralabel use of this drug was not in compliance with 21 CFR 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused it 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 existing at your facility. As a producer of animals offered for use as food, you are responsible for assuring your overall operation and the foods you distribute are in compliance with the law.
You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to achieve prompt corrective action may result in regulatory action, without further notice. This may include 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 you have taken or will take to correct the violations and prevent the recurrence of similar violations. 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 corrections have been made.
Your written response should be sent to Richard T. Trainor, Compliance Officer, at the following address: FDA, 300 Hamilton Ave., White Plains, New York 10601. If you have any questions about this letter, please contact Mr. Trainor at (914)682-6166 X34.
Edward W. Thomas
Acting District Director