"Specifically, your firm manufactures a preblend that is subsequently used by other firms in the manufacture of animal food products, and your reliance on your prerequisite programs failed to reduce the probability that a vitamin D nutrient toxicity will occur in your animal food in the absence of a preventive control."
FDA Warning Letter
ADM Animal Nutrition
MARCS-CMS 657846 — OCTOBER 23, 2023
MARCS-CMS 657846 — OCTOBER 23, 2023
Recipient:
Todd Wiessing
Plant Manager
ADM Animal Nutrition
1200 McGrath Avenue
Effingham, IL 62401
United States
todd.wiessing@adm.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
CMS Case #657846
October 23, 2023
Dear Mr. Wiessing:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your vitamin and mineral premix and preblend animal food manufacturing facility, located at 1200 McGrath Avenue, Effingham, Illinois 62401 on March 13 through March 16, 2023. The inspection was in response to a Class I recall initiated by your customer on February 8, 2023, and expanded on March 10, 2023, due to elevated levels of vitamin D in a prescription diet dry dog food after receiving consumer complaints of illness. The inspection occurred after you filed Reportable Food Registry (RFR) reports on February 14, 2023, and March 15, 2023, for elevated levels of vitamin D in several lots of your preblend AA Diet and after products containing the AA Diet were recalled.1
During the inspection, FDA’s Investigators found evidence of a significant violation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements found in Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507) which causes your products to be adulterated.2 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.3 Also, the failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls requirements of 21 CFR Part 507 is a prohibited act.4
You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We acknowledge your written responses dated April 6, 14, and 20, 2023. We have reviewed your responses and address your corrective actions below, in relation to the noted violation.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, the FDA Investigators identified a significant violation of these requirements:
You failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1).
Specifically, your firm manufactures a preblend that is subsequently used by other firms in the manufacture of animal food products, and your reliance on your prerequisite programs failed to reduce the probability that a vitamin D nutrient toxicity will occur in your animal food in the absence of a preventive control. In your hazard analysis, "HAZARD ANALYSIS BY SPECIES,” you identified a high severity of vitamin D toxicity in dogs and determined the probability of occurrence was reduced by the proper formulation of dog foods. Under “HAZARD ANALYSIS OF PROCESSING STEPS” at the (b)(4) steps, you identified toxicity from adding the wrong ingredient as a known or reasonably foreseeable food safety hazard. Your hazard analysis further states this hazard does not require a preventive control as you rely on your prerequisite programs to manage the hazard of vitamin D toxicity in food for dogs. Your prerequisite programs include (b)(4). Also, high risk ingredients are to be (b)(4) and discrepancies investigated. However, the findings of elevated levels of vitamin D in several lots of your AA Diet preblend indicate your prerequisite programs were insufficient or you failed to implement them adequately to ensure the inclusion of vitamin D did not result in a nutrient toxicity.
Evaluation of your response:
In your written responses to the Form FDA 483, you state that your investigation determined that your prerequisite programs failed to prevent the wrong ingredient from being added to two lots of the AA Diet Internal Premix. You further state that you are in the process of implementing a new process preventive control for vitamin D hazards. Your corrective actions included moving all vitamin D ingredients to a designated storage area of your warehouse and conducting a review of your vitamin D ingredients to identify those that contain more than (b)(4) vitamin D as “high-risk”. Ingredients containing less than (b)(4) vitamin D were determined to be a lower risk because the incorrect addition of those ingredients at levels that would create a nutrient toxicity hazard would be high enough to trigger a production yield variance investigation. In addition, you implemented a (b)(4) to better identify all vitamin D ingredient pallets and individual containers. You also submitted a copy of “EFF.QA.SOP.155 High-Risk Vitamin D Ingredient Reconciliation” standard operating procedure (SOP) as well as copies of blank documents to show how these inventory records and reconciliations will be conducted by each shift.
We are unable to fully evaluate your corrective actions since you did not provide documentation demonstrating the implementation and effectiveness of the new process preventive control. Your April 14, 2023, response indicates that the new SOP has been implemented and operator training will be conducted prior to the start of production on April 16, 2023. However, your April 20, 2023, response does not provide any further updates regarding your vitamin D corrective actions such as training records, your updated hazard analysis with the new preventive control, photographs of labeled pre-weighed ingredients, or other documentation demonstrating the consistent implementation of your updated corrective actions. FDA will evaluate your corrective actions during the next inspection.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal action, including without limitation, seizure and injunction.
We also have the following comment:
In response to discussion with our Investigators about your grain product sampling procedures for mycotoxin testing, your April 2023 response letters described actions you have taken or are planning to take with regard to this issue. You stated you will begin to follow your MPC-19 Mycotoxin Controls prerequisite program by (b)(4). In addition, you stated you are implementing a new SOP (“EFF.QA.SOP.106 Mycotoxin Procedure”) for your mycotoxin prerequisite program that covers bulk and bagged incoming grain and grain byproducts. You indicated all operators would be trained on the procedure. Upon review of your new SOP, we noted that it does not clearly state your mycotoxin testing frequency or which mycotoxin test you will apply to each incoming ingredient you identified. We encourage you to refine and consistently implement your mycotoxin hazard prerequisite program. A robust prerequisite program is needed to adequately reduce the probability that a hazard will occur in the absence of preventive controls.
For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal action, including without limitation, seizure and injunction.
We also have the following comment:
In response to discussion with our Investigators about your grain product sampling procedures for mycotoxin testing, your April 2023 response letters described actions you have taken or are planning to take with regard to this issue. You stated you will begin to follow your MPC-19 Mycotoxin Controls prerequisite program by (b)(4). In addition, you stated you are implementing a new SOP (“EFF.QA.SOP.106 Mycotoxin Procedure”) for your mycotoxin prerequisite program that covers bulk and bagged incoming grain and grain byproducts. You indicated all operators would be trained on the procedure. Upon review of your new SOP, we noted that it does not clearly state your mycotoxin testing frequency or which mycotoxin test you will apply to each incoming ingredient you identified. We encourage you to refine and consistently implement your mycotoxin hazard prerequisite program. A robust prerequisite program is needed to adequately reduce the probability that a hazard will occur in the absence of preventive controls.
For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:
Guidance for Industry #235: “Current Good Manufacturing Practice Requirements for Food for Animals” https://www.fda.gov/media/97464/download
Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” https://www.fda.gov/media/110477/download
Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program” https://www.fda.gov/media/113923/download
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Dylan C. Grippi, Compliance Officer, at 300 River Place Drive, Suite 5900, Detroit, MI 48207 or via email (preferred) to Dylan.Grippi@fda.hhs.gov and orahafeast6firmresponses@fda.hhs.gov. Please ensure your facility name, Firm Establishment Identifier (FEI) and establishment address are included in the correspondence. If you have any questions about this letter, please contact Mr. Grippi at (301)452-1608, or by e-mail at Dylan.Grippi@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations East 6
___________________________
1 Although vitamin D is an essential nutrient that allows dogs to regulate the balance and retention of calcium and phosphorus, when high levels of vitamin D are consumed, excessive amounts are not excreted but are stored in fat tissue and the liver. The adverse health consequences from consuming excessive levels of vitamin D can lead to kidney failure and even death. Food and Drug Administration. 2023. “Vitamin D Toxicity in Dogs.” Accessed June 26, 2023. https://www.fda.gov/animal-veterinary/animal-health-literacy/vitamin-d-toxicity-dogs
2 See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
3 See Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
4 See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].
Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” https://www.fda.gov/media/110477/download
Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program” https://www.fda.gov/media/113923/download
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Dylan C. Grippi, Compliance Officer, at 300 River Place Drive, Suite 5900, Detroit, MI 48207 or via email (preferred) to Dylan.Grippi@fda.hhs.gov and orahafeast6firmresponses@fda.hhs.gov. Please ensure your facility name, Firm Establishment Identifier (FEI) and establishment address are included in the correspondence. If you have any questions about this letter, please contact Mr. Grippi at (301)452-1608, or by e-mail at Dylan.Grippi@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations East 6
___________________________
1 Although vitamin D is an essential nutrient that allows dogs to regulate the balance and retention of calcium and phosphorus, when high levels of vitamin D are consumed, excessive amounts are not excreted but are stored in fat tissue and the liver. The adverse health consequences from consuming excessive levels of vitamin D can lead to kidney failure and even death. Food and Drug Administration. 2023. “Vitamin D Toxicity in Dogs.” Accessed June 26, 2023. https://www.fda.gov/animal-veterinary/animal-health-literacy/vitamin-d-toxicity-dogs
2 See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
3 See Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
4 See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].
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