- Delivery Method:
- VIA EMAIL WITH READ RECEIPT
- Animal & Veterinary
Food & Beverages
- Effingham Equity
201 W. Roadway Avenue
Effingham, IL 62401
- Issuing Office:
- Division of Human and Animal Food Operations East VI
FY 22-HAFE6-09 CMS 628068
September 20, 2022
Mark L. Cullen, Senior Vice President
Dear Messrs. Vernon and Cullen,
The U.S. Food and Drug Administration (FDA) inspected your licensed medicated and non-medicated animal food manufacturing facility located at 201 W. Roadway Ave., Effingham, Illinois 62401, from December 13, 2021, through January 31, 2022. You produce food for swine, beef cattle, dairy cattle, sheep, goats, poultry, and rabbits at your facility.
The inspection revealed evidence of significant violations of the Hazard Analysis and Risk-Based Preventive Controls for Food for Animals requirements, in Title 21 of the Code of Federal Regulations (21 CFR), Part 507, and Current Good Manufacturing Practice for Medicated Feeds requirements, in 21 CFR Part 225, which cause your products to be adulterated.1, 2 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.3 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 (located in subparts A, C, D, E, and F) is also a prohibited act.4 You may find the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s regulations through links on the FDA’s website at www.fda.gov.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We received your February 21, 2022, response to the observations listed in the Form FDA 483 and address your corrective actions below.
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 Investigator 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 preventive controls, as required by 21 CFR 507.33(c)(1).
Specifically, your reliance on your prerequisite program failed to reduce the probability that excessive levels of mycotoxins will occur in your animal food in the absence of a preventive control. You rely on your prerequisite program, “43.0 Ingredient Toxin Testing SOP,” to manage the hazard of mycotoxins, including aflatoxin and fumonisin, in animal food. Your “43.0 Ingredient Toxin Testing SOP” states, “If toxins are found in an ingredient at levels higher than the recommended amounts, special accommodations will be made to segregate product or reject all together.” However, your procedures fail to list the levels of aflatoxin, fumonisin, or vomitoxin that are considered to be "higher than recommended amounts" that would require you to segregate or reject the product.
Without specified levels, your prerequisite program could not be implemented in a way that reduces the probability of occurrence of mycotoxins, as evidenced by the elevated levels of aflatoxin and fumonisin in the (b)(4) you received from your grain division, which was then used as an ingredient in your animal food products for dairy cows or immature animals. Between September 20, 2021, and November 9, 2021, your facility sampled incoming (b)(4) received from your facility's grain division and submitted them to a third-party laboratory to be analyzed for the presence of aflatoxin and fumonisin, per your facility's SOP. Four of the (b)(4) samples collected were found to have aflatoxin levels of 53.16 ppb, 34.23 ppb, 120.46 ppb, and 129.76 ppb, which exceed FDA’s recommended action levels in (b)(4) and (b)(4) of 20 ppm for lactating dairy cattle and immature animal food.5 On October 13, 2021, you formulated (b)(4) feeds using the (b)(4) assayed at 129.76 ppb of aflatoxin to be fed to dairy cows or immature animals.
In addition, one of the (b)(4) samples collected was found to have a fumonisin level of 11,586 ppb (11.586 ppm), which exceeds FDA’s recommended maximum levels in (b)(4) and (b)(4) of 5 ppm for food for rabbits and 10 ppm for food for deer and immature cattle, sheep, and goats less than 3 months of age.6 You routinely manufacture food for these types of animals.
Therefore, the hazard of excessive levels of mycotoxins were not properly managed and you did not reduce the probability that the hazard would occur in the absence of a preventive control.
Your written response to the Form FDA 483 describes a new preventive control for the hazards of aflatoxin, fumonisin, and deoxynivalenol (DON/vomitoxin) for grain and grain co-products, which includes measures such as your “Receiving Procedure, Specifications, Toxin Testing Procedure, and Supplier Control.” You also submitted a revised “QP.43 Toxin Testing Procedure” (previously referred to as “43.0 Ingredient Toxin Testing SOP”) that includes charts that state maximum levels for aflatoxin, fumonisin, and vomitoxin in certain grains and grain co-products.
Your corrective action response is inadequate due to the following:
- You receive various grain and grain co-products susceptible to mycotoxins, such as (b)(4). However, your revised toxin testing procedure does not include any grain or grain co-products other than bulk corn received from the adjacent Effingham Equity grain storage facility.
- The maximum levels for fumonisin in (b)(4) and (b)(4) co-products included in your revised toxin testing procedure exceed FDA’s recommended maximum levels for all species and classes of animals for which you identified a maximum level (except equine), and you did not identify a maximum level for dairy cattle. Additionally, your revised procedure only identifies the total ration (finished product) maximum levels for swine and poultry.
- Your revised toxin testing procedure does not clearly identify the frequency for toxin testing.
Additionally, although you provided internal and external testing results for incoming grain, we are unable to fully assess the adequacy of your response because the documentation provided failed to demonstrate the frequency of sampling and testing as well as the implementation of your revised testing procedure.
2. You did not conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 507.33(a)(1). Specifically:
You did not identify the following known or reasonably foreseeable hazards for all incoming grain and grain co-products:
- Vomitoxin in (b)(4) and (b)(4)
- Aflatoxin in (b)(4) and (b)(4)
- Aflatoxin, fumonisin, or vomitoxin in (b)(4)
Once you identify known or reasonably foreseeable hazards for incoming grain and grain co-products, you will need to evaluate the severity of the illness or injury if the hazards were to occur, and the probability that the hazards would occur in the absence of preventive controls, to determine whether the hazards require a preventive control.
Your written response included a revised hazard analysis with sections for ingredients including (b)(4). You also reported that your facility has discontinued the use of cotton seed as an ingredient. Your revised hazard analysis identifies the hazard of fumonisin in (b)(4) and (b)(4) at the ingredient receiving step. However, the revised hazard analysis no longer includes fumonisin as a known or reasonably foreseeable hazard for (b)(4).
Additionally, your revised hazard analysis dated February 19, 2022, does not identify the mycotoxins of aflatoxin, fumonisin, and vomitoxin as known or reasonably foreseeable hazards in (b)(4). (b)(4) is a co-product of (b)(4) and therefore should be evaluated for the hazard of these mycotoxins.
Medicated Feed Current Good Manufacturing Practice (CGMP) Requirements
As a licensed medicated feed mill operator, you are required to follow the medicated feed CGMP regulations found in 21 CFR 225.1-225.115. During the inspection of your facility, the FDA Investigator observed evidence of a significant violation of the medicated feed CGMP requirements for licensed medicated animal feed manufacturers:
3. You did not properly identify drugs in the mixing areas to maintain their integrity and identity, as required by 21 CFR 225.42(b)(4).
Specifically, during the inspection, an unlabeled pail containing a yellow, granular material was observed in the mixing area next to the (b)(4) ingredients dump. The pail observed had no marking on it and no identity (i.e., tag or weigh sheet) that indicated the amount or identity of its contents. According to your facility’s feed mill superintendent, the pail contained (b)(4) medicated article that had previously been weighed for use in the feed currently being mixed, and these pails are only used to (b)(4).
In your written response, you provided an updated SOP, “QP. 19 (b)(4) Procedure,” which states that “[e]ach bucket with medication in it must be labeled with the drug name and drug amount.” However, we are unable to determine the adequacy of your corrective actions because you did not provide any evidence to demonstrate that the promised corrections have been implemented. We encourage you to provide evidence, such as photographs of the labeled buckets or other documentation demonstrating the implementation of your new procedure, to show that these changes have been made.
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.
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
- 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 directed to the Food and Drug Administration, attention to: Lauren Crivellone, Compliance Officer 550 West Jackson Boulevard, Chicago, IL 60661. You may email a copy of your response with appropriate attachments to email address: firstname.lastname@example.org. Please ensure your facility name, Firm Establishment Identifier (FEI) and establishment address are included in the correspondence. If you have questions regarding any issues in this letter, please contact Ms. Crivellone at (312) 206-5264 or my email at Lauren.Crivellone@fda.hhs.gov.
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations East 6
1 See Section 402(a)(4) of the 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 501(a)(2)(B) of the FD&C Act [21 U.S.C. § 351(a)(2)(B)].
3 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)]
4 See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].
5 See Compliance Policy Guide Sec. 683.100 Action Levels for Aflatoxins in Animal Feeds, available at https://www.fda.gov/media/121202/download.
6 See Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-fumonisin-levels-human-foods-and-animal-feeds.