- Animal & Veterinary
- Ridley Block Operations Inc
- Issuing Office:
- Cincinnati District Office
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
August 3, 2017
Mark D. Nelson, President
Ridley Block Operations
111 West Cherry St, Suite 500
Mankato, MN 56001
Dear Mr. Nelson,
On December 14, 2016 – January 19, 2017 and January 25, 2017, the U.S. Food and Drug Administration (FDA) conducted an investigation of your operation located at 334 Industrial Drive, Flemingsburg, KY 41041. The inspection was conducted in response to a Reportable Food Registry (RFR) report regarding the death of nine cattle due to urea toxicity after the cattle consumed your product (b)(4)
, which contained high levels of non-protein nitrogen (NPN). This event was reported to FDA on December 13, 2016. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA’s web page at www.fda.gov
We found that this animal feed manufactured at your facility was adulterated because it bears or contains an excessive amount of NPN, a poisonous or deleterious substance which may render it injurious to health (section 402(a)(1) of the Act [21 U.S.C. 342(a)(1)]). Furthermore, this product is misbranded because the labeling is false or misleading (section 403(a)(1) of the Act[21 U.S.C. § 343]) because it does not accurately describe the amount of NPN in the product.
During the inspection, FDA collected documentation and confirmed that a cattle feed manufactured and distributed by your facility contained excessive levels of NPN. This feed, (b)(4) lot (b)(4), was manufactured on or about 8/25/16 and distributed on 9/2/16. This feed was later identified by your facility as the cause of cattle deaths due to urea toxicity. Sample results obtained by your facility for this lot of feed found levels of NPN at 31.1% and 30.5%. While NPN is a common ingredient in ruminant feeds, NPN at an excessive level that contributed to the death of animals renders the animal feed adulterated. The label for this product indicates a maximum of 16% equivalent crude protein from non-protein nitrogen. As a result, the animal feed is misbranded.
FDA acknowledges receipt of your written response to the FDA483 (Inspectional Observations) dated 1/30/17. We acknowledge that you have suspended production of large quantity composite runs and plan to install a controlled batching system. However, your response does not provide detailed corrective actions, such as a timeline for implementation or new operating procedures, for the manufacturing operations and controls of the small volume custom runs that you intend to continue to manufacture.
The above is not intended to be an all-inclusive list of violations. As a producer of animal feed, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law. 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 do so may result in regulatory action without further notice such as seizure and/or injunction.
In addition to this specific lot, our Investigators note that sampling and analysis by the Kentucky, Indiana and Virginia state feed regulatory programs have identified numerous lots of product that have been sampled and found to contain nutrient levels outside (above and/or below) the analytical variations used by those states, which demonstrates that this misbranding may not be limited to a single product.
In addition, your facility is now subject to the current Good Manufacturing Practice requirements (CGMPs) for food for animals (21 CFR part 507, subpart B). Animal food that is not manufactured, processed, packed, and held according to CGMPs may be considered adulterated (21 CFR 507.1(a)(1)(i-ii)). Compliance with the CGMPs should reduce the likelihood that animal food from your facility is adulterated because it is contaminated, or because it was produced under conditions that could result in contamination.
We encourage you to review Draft Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals, which can be found on FDA's website
. There are a few CGMP regulations in part 507 that are directly applicable to the situation above, and which we would like to summarize for your reference. Specifically, the requirements in 21 CFR 507.25 address “plant operations”, which is the part of the regulations that covers the receipt and handling of raw materials and other ingredients, as well as product manufacturing, packaging and labeling. Here are some examples:
- 21 CFR 507.25(a)(5) requires that management of the establishment must ensure adequate precautions are taken so that plant operations do not contribute to the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials. This is a general requirement that establishes that it is management’s responsibility to operate the plant in a manner that produces safe animal food.
- 21 CFR 507.25(a)(7) requires that when animal food has become adulterated, management of the establishment must ensure that it is rejected, disposed of, or appropriately treated or processed to eliminate the adulteration. Your facility calculates a yield variance of a batch based upon the quantity of wet ingredients used. The inspection revealed that you identified batch yield variances outside of your acceptable range; however, the products were still held for sale and/or distributed. It is unclear whether your range is set for food quality, or food safety reasons, but if yield levels indicate an animal food may be adulterated, you must follow this CGMP requirement.
- 21 CFR 507.25(b)(1) requires that raw materials and other ingredients must be examined to ensure they are suitable for manufacturing and processing into animal food. In discussions, you indicated that the manual adjustments to the ratio of wet to dry ingredients were because of inconsistencies in incoming raw ingredients. If raw materials or other ingredients are not suitable for your manufacturing process, they should be rejected or used in a manner that can result in a properly formulated animal food that is not adulterated.
- 21 CFR 507.25(c)(4) requires that manufacturing and processing steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and cooling must be done in a way that protects against the contamination of the animal food. This would apply to the methods used to measure and mix the ingredients, where the operators routinely make batch to batch adjustments to the mixture of wet and dry feed ingredients. This inconsistency is well-documented by your internal quality control records that some batches of product are too hard to eat, others are so soft that cattle eat too much, or that the tubs did not cure and could not be shipped.
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 each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action 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 Andrew Lang, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Andrew Lang at 513-679-2700 x 2117.
Steven B. Barber
Director, Division V
Office of Human and Animal Food Operations: East