A complaint by a local dairy farmer sent the U.S. Food and Drug Administration to the Goshen, CA-based Western Milling Company for a comprehensive inspection last March 18-31.
Western Milling, a unit of O.H. Kruse Grain & Milling Company, is a non FDA-licensed feed manufacturing facility. The inspection found “significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for medicated feeds.
“Such deviations caused the animal feed being manufactured at the facility to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 351(a)(2)(B),” FDA said in a recently released July 6 warning letter to Western Milling.
“In addition, several labeling deviations were observed that cause certain animal feed products manufactured by your firm to be misbranded foods under section 403(a)(1) of the Act, 21 U.S.C. § 342(a)(1),” the warning letter continued.
FDA said it found Western Milling failed to implement adequate safeguards to prevent unsafe contamination in the production of medicated and non-medicated feeds. Western Milling, for example, was not using the product FDA recommends as a flush following the manufacture of medicated feed.
“The written cleanout procedure mentions “sequencing” but does not explain what sequencing is and does not contain a written sequencing plan. We do not believe this is a sufficient amount of direction to be effective,” the warning letter added.
FDA found not all deliveries of medicated animal feeds were properly labeled to ensure proper use.
“Specifically, we found a number of customer-formula medicated feeds whose label did not contain the directions-for-use or other information relative to the medication that is required by the drug approval regulations, FDA said.
Information on some documents did not line up.
FDA said the specific violations noted in the warning letter and the inspection report (Form 483) “may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the cause of the violations, take prompt actions to connect the violations and prevent their recurrence, and to bring your products into compliance. Failure to achieve prompt corrective action may result in regulatory action, without further notice, such as seizure and/or injunction.”
FDA said in response to the inspection report, Western Milling included a copy of its scale invoice, which included a copy of a customer-formula medicated feeds for dairy cows that was “incorrect and still needs some additional work.”
“Although it appears from the response that you are working toward correcting the deviations noted at your facility, you must adequately implement and maintain each corrective action to ensure its effectiveness,” the FDA warning letter concluded.
Western Milling was given 15 working days to respond to FDA’s concerns.