It is interesting in that the company stated in the hazard analysis that although Vitamin D was identified as a hazard in the formulation, it would be controlled through prerequisite programs. This of course failed with high Vitamin D levels getting into their premix and thus their customer's finished product and then finally that product impacting dogs.
Another interesting point to note is that the responses provided by the company to FDA were viewed as inadequate. Although the company stated that they took corrective action after the incident, including making hazardous ingredient addition a preventive control, they did not provide FDA sufficient documentation for the control of their process. The FDA response states, the company "did not provide sufficient supporting documentation, such as revised standard operating procedures, test results, or other documentation, to show that you have implemented these proposed corrective actions. For example, your supporting documentation for (b)(4) reconciliation includes only the record of a (b)(4) reconciliation on June 21, 2019. We are unable to determine the adequacy of relabeling, (b)(4), and (b)(4) at controlling the hazard because the batches with elevated levels of vitamin D occurred despite a (b)(4) process and (b)(4). With respect to your preventive control, you have identified (b)(4) per lot as the allowable variance for your process control. It is unclear whether that variance would ensure that vitamin levels would result in an animal food for which nutrient toxicity or deficiency is controlled. FDA will verify the adequacy of your corrective actions during the next inspection of your firm."
Warning Letter
DSM Nutritional Products, LLC
MARCS-CMS 578300 — October 11, 2019
MARCS-CMS 578300 — October 11, 2019
