- Delivery Method:
- Via Overnight Delivery
- Animal & Veterinary
Food & Beverages
Recipient NameMr. Rick Duncan
Recipient TitlePlant Manager
- Purina Animal Nutrition LLC
1402 E. Sarah DeWitt Dr.
Gonzales, TX 78629
- Issuing Office:
- Division of Human and Animal Food Operations West III
March 8, 2022
Dear Rick C. Duncan:
The U.S. Food and Drug Administration (FDA) inspected your animal food manufacturing facility located at 1402 E. Sarah DeWitt Dr., Gonzales, Texas on November 1 through November 10, 2021. This inspection was conducted as a follow-up to a Class I recall of four products initiated by your firm, due to elevated levels of urea. The affected products were distributed between October 15, 2021, and October 29, 2021, and included the following Purina animal food: Antler Advantage Wildlife 16 ARS; 4-Square Breeder 20; Precon Cattle Starter; and 4-Square Stocker/Grower 14. Elevated urea levels can cause serious health issues and death in ruminant animals including cattle, deer, antelope, and sheep.
During our inspection, FDA Investigators found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507) which cause your products to be adulterated.1 The doing of any act to a food after shipment of the food and/or its components in interstate commerce and while the food is held for sale (whether or not the first sale) that results in the food being adulterated or misbranded is prohibited.2 Furthermore, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provision of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is also a prohibited act.3 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 (FDA 483). We have not received a response to the FDA 483 as of the date on this letter.
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, FDA Investigators noted evidence of significant violations of these requirements, which included but were not limited to the following:
1. Your facility failed to sufficiently assess the probability that a hazard will occur in the absence of a preventive control, as required by 21 CFR 507.33(c)(1).
Your reliance on prerequisite programs in your food safety plan failed to reduce the probability that the presence of an unsafe level of urea will occur in the absence of a preventive control. Your firm uses urea as an ingredient in some of your products; however, your firm failed to implement your prerequisite programs to ensure that your animal food products did not contain an excess of urea, which is a known or reasonably foreseeable hazard for ruminants, that could occur in the absence of a preventive control.
As stated in your Process Hazard Analysis, you were relying on your prerequisite programs—Materials Management & Warehousing Program, Manufacturing Control Program, and Bulk Ingredient Receiving Program—to mitigate the hazard of excess urea. However, the prerequisite programs you identified in your hazard analysis are not operating in a way that reduces the probability of occurrence, as evidenced by your statement that urea was added to the reprocessed material (RPM) bin in error on October 13, 2021, causing the contamination of the RPM ingredient which was subsequently used to manufacture animal food. Furthermore, on October 26, 2021, you recalled four animal food products manufactured by your firm due to elevated levels of urea. Therefore, the hazard of excess urea in food for ruminants was not properly managed and you did not reduce the probability that the hazard would occur in the absence of a preventive control.
Current Good Manufacturing Practices (CGMP) Requirements
Your animal food facility is subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, and F. During the inspection of your facility, FDA Investigators noted evidence of significant violations of these requirements, which included but were not limited to the following:
2. You did not ensure adequate precautions were taken so that plant operations do not contribute to contamination of animal food, animal food-contact surfaces, and animal food-packaging materials, as required by 21 CFR 507.25(a)(5).
Specifically, you stated that on (b)(4), your firm received (b)(4) lbs. of urea, (b)(4) to (b)(4) of which was initially unloaded into the wrong receiving pit by the receiving employee. Upon realizing the product was being unloaded into the wrong pit, the receiving employee discontinued the unloading and diverted the (b)(4) to (b)(4) of unloaded urea to the re-processed materials (RPM) Bin (b)(4), which your manager stated is not allowed. However, your “Bulk Ingredient Receiving Log – Truck” documents that the entirety of the load was placed into the designated urea Bin (b)(4). Furthermore, your “Truck Bulk Ingredient Receiving Work Instructions” state that in the event of unloading into the wrong receiving pit, the receiving employee is to notify a supervisor or plant manager immediately, which did not occur. As a result of inadequate precautions against the introduction of an additive of concern into your animal food, your production records show that (b)(4) lbs. of the RPM containing the urea was used as an ingredient in multiple animal foods you manufactured on (b)(4) and (b)(4).
3. You did not ensure that animal food that has become adulterated is rejected, disposed of, or if appropriate, treated or processed to eliminate the adulteration, as required by 21 CFR 507.25(a)(7).
Specifically, at least (b)(4). ((b)(4)lb bags) of the Precon Cattle Starter food, which was part of the recall initiated by your firm on October 26, 2021 due to excess urea content, was sold and distributed to a (b)(4) buyer on October 29, 2021.
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 you comply with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction.
We also have the following comments:
1. In your “Drug & Additives of Concern – Hazard Assessment,” effective October 1, 2020, you list all medicated articles and additives used in the manufacture of animal food by your facility. For the additive “NPN Source % (Urea, Ammonium Chloride, Ammonium Sulfate, Diammonium phosphate, Mono-ammonium phosphate, etc.),” you do not list any chemical hazards or any existing toxicities associated with these additives. However, toxicities are associated with non-protein nitrogen (NPN) ingredients when ingested in excessive concentrations and NPN toxicity can cause acute disease, including death in ruminants. In your revised Hazard Analysis, effective October 27, 2021, you did not identify NPN toxicities individually and as high severity, even after the reanalysis-triggering event. Please provide your justification for not identifying NPN ingredients individually and as high severity during the revision of your hazard analysis.
2. During the inspection, on November 3, 2021, you stated that the (b)(4) buyer had not been identified in your list of consignees and you had not notified the buyer that the product they received was among the products affected by the recall. You are responsible for promptly notifying each affected direct account about a recall. See 21 CFR 7.49 for information on recall communications. We acknowledge that you stated you informed the (b)(4) buyer about possible urea contamination of the product on November 4, 2021.
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
- Draft Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” https://www.fda.gov/media/110477/download
- Draft 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 response should be sent to U.S. Food and Drug Administration, Office of Human and, Animal Food Operations West Division 3, Attention: Dana Lewis, 1201 Main St, Suite 7200, Dallas, Texas 75202 or by email to Dana.Lewis@fda.hhs.gov. If you have questions regarding this letter, please contact Dana Lewis at (214) 253-5205.
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
Cc: Beth Ford, CEO/President
Land O’Lakes, Inc.
4000 Lexington Avenue North
Arden Hills, MN 55126
Lisa Deverell, President
Purina Animal Nutrition, LLC
4001 Lexington Avenue North
Arden Hills, MN 55126
Mary Sasser, Program Director
Office of the Texas State Chemist
445 Agronomy Road
College Station, Texas 77843
1 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)].
2 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
3 See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].