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WARNING LETTER
FY22-HAFE6-04 CMS 621812

February 4, 2022

Dear Al Riedstra:

Between September 2 and November 2, 2021, the United States Food and Drug Administration (FDA) conducted an inspection of your dairy farm operation, known as Riedstra Dairy, Ltd., located at 55985 Frank Jones Rd., Mendon, Michigan. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were revealed during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on the FDA’s webpage at www.fda.gov.

Adulteration of an Animal Offered for Human Consumption

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(a)(4)(B) of the FD&C Act (21 U.S.C. § 360b(a)(4)(B)), a drug is unsafe if it results in any residues that exceed any established safe levels.

Specifically, our investigation revealed that on November 16, 2020, you sold a cow identified with yellow bangle tag number (b)(4) for slaughter as food. On November 17, 2020, (b)(4), of (b)(4), slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur at 0.568 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur, a metabolite breakdown of ceftiofur class drugs, in uncooked edible kidney tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), section 556.113(b)(1)(i) (21 CFR § 556.113(b)(1)(i)). The presence of this drug in edible tissue in excess of this amount causes the food to be adulterated.

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 has been held under insanitary conditions whereby it may have been rendered injurious to health. Our investigation found that you hold animals under conditions that are inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you lack an adequate system to ensure that medicated animals are withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete and accurate treatment records. On October 6, 2021, our Investigator observed your staff medicate dairy cattle with (b)(4) (ceftiofur hydrochloride, NADA (b)(4)); however, these treatments were not subsequently entered into your records used to make culling decisions. Your records also did not consistently include the route of administration for treatment. You also do not maintain a drug inventory system for determining the quantities of drugs used to medicate your cows.

Adulteration of a New Animal Drug

We also found that you adulterated the new animal drug (b)(4) (ceftiofur hydrochloride, NADA (b)(4)). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug in this manner is an extra-label use, as defined by 21 CFR § 530.3(a). Our investigation found that you administered (b)(4) in an extra-label manner by injecting more than (b)(4) per injection site during treatment. The on-label directions for use for this drug indicate that no greater than (b)(4) may be administered per injection site. Additionally, we found that you typically administer a standard dose of (b)(4) of (b)(4) per treatment day regardless of the weight of the cow, while the on-label directions indicate this drug must be administered at a dose of (b)(4)/100lbs in dairy cattle. Our investigation observed significant weight variation in the cattle on your farm, so this treatment regime can result in overmedication and undermedication of your livestock. Your “standard dose” is therefore an extra-label use of the drug. (b)(4) is a cephalosporin antibiotic, which is prohibited from extra-label use at unapproved doses in food-producing animals per 21 CFR § 530.41(a)(13)(ii).

Lastly, our investigation found that you used (b)(4) to treat cattle for mastitis and Salmonella. This drug is not labeled for these conditions in food-producing animals. The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use complies with sections 512(a)(4) and (5) of the FD&C Act (21 U.S.C. §§ 360b(a)(4) and (5)), and 21 CFR § 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 as defined by 21 CFR § 530.3(i)(1). However, your extra-label use of this drug was not by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Because your use of this drug was not in conformance with the approved labeling and did not comply with 21 CFR § 530, you caused the drug to be unsafe under section 512(a)(4)(A) of the FD&C Act (21 U.S.C. § 360b(a)) and adulterated within the meaning of section 501(a)(5) of the FD&C Act (21 U.S.C. § 351(a)(5)).

To date we have not received correspondence from you addressing the inspectional observations or the steps you are taking to correct these issues.

Conclusion

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.

In addition to the violations described above, we also would like to note:

Our investigation also found your firm responsible for causing an additional drug residue; specifically, on April 24, 2020, you sold and delivered a cow identified with ear tag number (b)(4) for slaughter as food. The animal was slaughtered the same day at (b)(4), of (b)(4). The USDA/FSIS analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur at 2.599 ppm in the kidney tissue.

FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur, a metabolite breakdown of ceftiofur class drugs, in uncooked edible kidney tissues of cattle as codified in 21 CFR § 556.113(b)(1)(i).

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 Darren S. Morgan, Compliance Officer, at 300 River Place Drive, Suite 5900, Detroit, MI 48207 or via email (preferred) to Darren.Morgan@fda.hhs.gov. If you have any questions about this letter, please contact Mr. Morgan at (419) 490-7467, or by email at Darren.Morgan@fda.hhs.gov.

Sincerely,
/S/

William R. Weissinger, MS
District Director | FDA Chicago District
Program Division Director
Office of Human and Animal Food Operations East Division 6

CC: Dr. (b)(4)