Ridley Block Operations Inc FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

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(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.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Ridley Block Operations Inc.

Regulatory Context

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(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.