- Delivery Method:
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- Animal & Veterinary
Food & Beverages
Recipient NameArlin L. Benner
- Yippee Farms, LLC
1020 Pinkerton Road
Mount Joy, PA 17552-9242
- Issuing Office:
- Division of Human and Animal Food Operations East II
May 5, 2022
Dear Mr. Benner,
An inspection of your dairy operation located at 1103 Iron Bridge Road, Mount Joy, Pennsylvania, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on December 8 and 10, 2021. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were revealed during our inspection of your operation and noted upon further review of the information collected during the inspection. You can find the FD&C Act and its associated regulations on the internet through links on the FDA’s web page at www.fda.gov.
Our investigation found your firm responsible for causing drug residues of meloxicam and sulfadimethoxine in the kidney tissue of bob veal calf (b)(6). Specifically, on March 4, 2021, you sold this bob veal calf for slaughter as food. The animal was slaughtered on or about March 5, 2021, at (b)(4). The USDA/FSIS analysis of tissue samples collected from this animal identified the presence of meloxicam and sulfadimethoxine in the kidney tissue. FDA has not established a tolerance for residues of meloxicam and sulfadimethoxine, in uncooked edible tissues of this bovine animal class.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We have not received a response, from you, to the FDA 483 as of the date on this letter.
Adulteration of Animals Offered for Human Consumption
Our investigation 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. Specifically, you failed to maintain complete treatment records for a bob veal calf with farm tag (b)(6) when your employee did not record the administration of meloxicam and sulfadimethoxine on the pen treatment record for this animal. Due to the incomplete treatment records, the calf with farm tag (b)(6) was sold for slaughter before the proper meat withdrawal time indicated on the prescription label for the human drug meloxicam. Additionally, your treatment records, in general, do not identify the condition being treated for your medicated heifer calves. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)].
Adulteration of New Animal Drugs
Our inspection also revealed that you adulterated the human drug meloxicam (NDC (b)(4)) and the drug (b)(4) (sulfadimethoxine, NADA (b)(4)) because you failed to use the drugs in conformance with their approved labeling (“extralabel use”). Extralabel use is only permitted if the use complies with sections 512(a)(4) and 512(a)(5) of the FD&C Act [21 U.S.C. 360b(a)(4) and 360b(a)(5)], and with Title 21, Code of Federal Regulations, Part 530 (21 CFR Part 530), including that the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship as defined by 21 CFR 530.3(i)(1). Our investigation found that your extralabel use of meloxicam and (b)(4), however, failed to comply with these requirements.
• Around March 3, 2021, your employee treated a bob veal calf identified with farm tag (b)(6) with meloxicam and (b)(4) (sulfadimethoxine) for scours. Additionally, you stated that you routinely administer meloxicam for scours. However, the veterinary prescription label stated that meloxicam was prescribed to only treat pain in calves due to dehorning. Your use of the drug for scours was therefore an extralabel use.
• You administered meloxicam to bob veal calf identified with farm tag (b)(4) in an extralabel manner by not following the withdrawal period set forth in the veterinary prescription label, which is (b)(4). You stated that an employee medicated this animal with meloxicam at an unknown date prior to the calf being sold. This calf was only (b)(4) old when slaughtered for food; therefore, the calf could not have been held for the required withdrawal time of (b)(4).
• You administered (b)(4) (sulfadimethoxine) in an extralabel manner by treating a preruminant bob veal calf identified with farm tag (b)(6) for scours. The approved labeling of (b)(4) (sulfadimethoxine) (b)(4) states in part, “(b)(4)”.
Your extralabel use of meloxicam and (b)(4) (sulfadimethoxine) were not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
Because your extralabel use of these drugs was not in compliance with 21 CFR Part 530, you caused the drugs to be unsafe under sections 512(a)(4) and 512 (a)(5) of the Act [21 U.S.C. § 360b(a)(4)(A)] and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility. 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, and that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. 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 adequately address this matter may lead to legal or regulatory action without further notice, including without limitation, seizure and/or injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations and include copies of any available documentation demonstrating that corrections have been made. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Compliance Officer Andrew J. Howard at United States Food & Drug Administration, 11155 Dolfield Blvd, Suite 117, Owings Mills, MD 21117. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Howard by telephone at (410) 779-5125, or by email at Andrew.Howard@fda.hhs.gov.
Randy F. Pack
District Director/Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration