Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm583185.htm
Timestamp: 2019-01-21 03:45:25
Document Index: 309731045

Matched Legal Cases: ['§ 342', '§ 530', '§ 530', 'art 530', '§ 360', '§ 351']

Finnerty Dairy 10/25/17
FY18-HAFE6-02
Mr. Duane Finnerty, Owner
465 East Rosebush Road
On May 18, 2017 and August 8, 2017, the U.S. Food and Drug Administration conducted an investigation of your dairy operation located at 465 East Rosebush Road, Mount Pleasant, Michigan. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through 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 FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it had been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about September 12, 2016, you sold a culled dairy cow, identified with back tag # (b)(4) and ear tag # (b)(4), for slaughter as food. On or about September 13, 2016, (b)(4), slaughtered this animal.
The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue collected from this animal identified the presence of 0.157 parts per million (ppm) of sulfamethazine in the muscle and 0.241 ppm of sulfamethazine in the liver. Our investigation found that you administered Sustain III (NADA 120-615, sulfamethazine) to this cow.
FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.670 (21 C.F.R. 556.670).
However, pursuant to its labeling, Sustain III is prohibited from use in lactating dairy cattle. Therefore, this tolerance does not apply to the use of Sustain III, sulfamethazine in lactating dairy cattle. There is no acceptable level of sulfamethazine residue resulting from the use of Sustain III in lactating dairy cattle. The presence of this drug in edible tissues from this animal in these amounts therefore causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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 drug treatment records. For example, on May 18, 2017, you were unable to provide treatment records for cow with Ear Tag (b)(4). Additionally, your treatment records do not show what condition is treated, dosage, withdrawal times, or route of administration for all medications given. You also failed to maintain an adequate inventory system for determining the quantities of drugs used to medicate your animals which include the list of drugs, quantities, lot numbers, date used or expiration dates. You also fail to segregate treated animals. Specifically, you keep treated animals together in the same pen with non-treated animals. Although leg bands are used, they are removed after meeting milk withholding times. Milk withdrawals are typically shorter than meat withdrawals. A treated animal could be offered for sale before meat withdrawals are met. 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 drug Sustain III (NADA 120-615 sulfamethazine). Specifically, our investigation revealed that you did not use Sustain III as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. § 530.3(a).
Our investigation found that you administered Sustain III to lactating dairy cattle without following the animal class restrictions as stated in the approved labeling. According to its labeling, Sustain III is prohibited for use in lactating dairy cattle. Your use of Sustain III in a lactating dairy cow was therefore extralabel use. Under 21 C.F.R. § 530.41(a)(9), sulfonamide drugs are prohibited from extralabel use in lactating dairy cattle. Further, your extralabel use of sulfamethazine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). 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(s) 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 your overall operation and the food you distribute is in compliance with the law.
We acknowledge receipt of your undated letter, sent through the US Postal Service on August 17, 2017, and in response to the FDA 483, Inspectional Observations. In your response you indicated you have stop[ed] using sulfa [sulfamethazine], are keeping your records for a longer length of time and more detailed, and putting colored ribbons on the cows neck straps; you also provided a blank Daily Treatment Record. However, you did not provide details or procedures for how long these records will be kept and utilized to prevent residues, any updated treatment protocols to prevent unapproved extra label use, nor any evidence of an updated drug inventory system.
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 details on each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective actions 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 Michael Larson, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any question about this letter, please contact Compliance Officer Michael Larson at (313) 393-8155 or email at michael.larson@fda.hhs.gov.