Both the Farmers/Ranchers Cooperative Association of Ainsworth in Nebraska and Gilman Co-Op Creamery in Minnesota were found to be not adhering to the Current Good Manufacturing Practice (CGMP) requirements set for feed mills working with medicated feeds, said the FDA.
The FDA has warned the two feed mills about their handling and use of the animal drug.
Monensin has been approved for use in cattle, swine and poultry, but can be highly toxic or lethal to horses.
“The medicated feed CGMPs require firms to conduct appropriate sequencing or adequate equipment cleanout procedures when switching from mixing a medicated animal food to a non-medicated one,” the agency reported. “These regulations are designed to prevent unsafe cross-contamination between medicated feed and non-medicated feed or other medicated feed.”
The issue of livestock medication carryover or contamination in feeds as an “infrequent but persistent (and highly avoidable) problem,” a spokesperson with the agency told FeedNavigator.
“FDA recommends adhering to CGMP requirements to eliminate unsafe carryover of medications into feed intended for different species," she said.
Going forward, the agency recommends that users of equine feed may want to speak with their suppliers regarding other products that are generated from the feed mill, including if medicated feeds that contain ionospheres are manufactured at that location, she said.
Feed users also may want to ask about any special or specific precautions taken at the facility to “ensure there is no cross-contamination.”
Animal producers, owners, veterinarians and other stakeholders are encouraged to report issues with equine or livestock feeds if they suspect a potential contamination, said the spokesperson.
Warning letter details
The Farmers/Ranchers Cooperative has had two recalls of feed, for swine in 2018 and for horse feed in 2017, when samples tested by the Nebraska Department of Agriculture detected drug levels not approved for those feeds, the FDA said.
The swine feed was labeled non-medicated, yet found to include a level of the new animal drug chlortetracycline, while the horse feed contained monensin, the agency reported.
During an inspection in May, the cooperative was found to deviate from CGMP regulations in a manner that meant its non-medicated and medicated feeds were considered adulterated, the agency said. The company has since presented its corrective actions to address the situations, however, more information was requested.
“Your June 5, 2018 written response discusses your corrective actions for the Sandhills Select Horse feed and the non-medicated animal foods which NDA sampled and found to contain new animal drugs,” the FDA said. “Your response stated that you sent retained samples for analysis, updated the sequencing chart, and trained employees on the sequencing chart. However, this is not adequate because your response does not indicate you have investigated the cause of these two lab results.”
There could have been multiple actions that caused both feeds to include medications other than carryover from incorrect sequencing, the agency said. However, the corrective actions described do not address other situations and do not locate the cause of the initial problems.
During an investigation in May, the company also was found to have inadequate procedures in place for the storage, labeling and inventory of both Type A medicated articles and Type B medicated feeds, the agency said.
“During our inspection, we found multiple Type A medicated articles or Type B medicated feeds, used to further manufacture animal food, which were not accounted for in your inventory,” it added.
The company told the FDA it had changed procedures and had training sessions to address those concerns.
“In addition to the incidents listed above, in June 2018 your firm bagged urea into unmarked bags intended for internal use, which your employee mistakenly distributed as mono-calcium phosphate,” the agency said. “This product was subsequently fed to your customer’s cattle and resulted in the death of four cows and illness of two cows.”
The product was recalled, however, the FDA said, it continues to demonstrate a “lack of control” regarding how CGMPs are implemented.
Additionally, the FDA announced in July that it was conducting an ongoing investigation into Gilman Co-Op Creamery following the deaths of five horses after receiving a feed found to contain monensin. “FDA found through laboratory analysis that your custom Horse Blend 985 contained monensin,” the agency added.
“The presence of monensin in your Horse Blend 985 causes it to be unsafe because the animal food containing the new animal drug was not used in conformance with the drug approval as outlined in section 512(a)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act,” the FDA said.
During its review of the company, the FDA found “significant deviations” from established CGMPs, the agency said in its letter. These included that the cooperative had failed to set and use adequate steps for the equipment involved with manufacturing and distributing medicated feed. Records were reportedly kept in an inadequate manner and there was “insufficient procedural documentation.”
“On June 4, 2018, you manufactured a custom cattle mix containing (b)(4) (monensin),” the agency said. “After the manufacture of this medicated feed, it does not appear steps were taken to either flush or clean equipment. The two batches immediately following, a medicated bambermycin custom steer mix and a non-medicated custom Horse Blend 985, were both found to contain monensin.”
Although the cooperative noted in batching records that flushing is required with medicated feed, there was no documentation regarding if a flush had been done, the agency said.
“This is a repeat violation from the previous inspection where it was noted that your firm is not documenting on the production record when a flush occurs,” it added.
There also was “excessive build-up” on parts of a mixer at the facility and no set cleaning schedule set, the agency said. Build-up can lead to carry-over of ingredients, including drugs, from one feed batch to the next.