- Delivery Method:
- Via Overnight Delivery
- Animal & Veterinary
Food & Beverages
Recipient NameMr. John E. Evans
Recipient TitleVice President/Co-owner
- Evans Farms Feed
537 Lilley Road
Alvin, TX 77511-7143
- Issuing Office:
- Division of Human and Animal Food Operations West III
April 21, 2022
REF # 625841
Dear Mr. John E. Evans:
The U.S. Food and Drug Administration (FDA) inspected your animal food manufacturing facility (feed mill) located at 537 Lilley Road, Alvin, Texas on November 30, 2021 through December 9, 2021. This inspection was conducted as a follow-up to a consumer complaint received by FDA on October 26, 2021. The complaint was received (b)(4) reporting multiple horses at two locations that became ill, with some being hospitalized and one death, after consuming food manufactured by your facility. Private testing reportedly showed levels of fumonisin (b)(4) in the implicated horse food.1 Follow-up testing by the Office of the Texas State Chemist found (b)(4). Fumonisin levels above 1.0 ppm are known to cause liver disease and fatal nervous system damage in horses.
Our inspection revealed evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) regulation, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507) which cause your products to be adulterated.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 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.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 (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, the FDA Investigator noted evidence of significant violations of these requirements, which included but were not limited to the following:
1. You did not prepare, or have prepared, and did not implement a written food safety plan, as required by 21 CFR 507.31. The preparation of the food safety plan must be overseen by your preventive controls qualified individual (PCQI) and must include the following:
a) The written hazard analysis as required by 21 CFR 507.33(a)(2).
b) The written preventive controls as required by 21 CFR 507.34(b).
c) The written supply-chain program as required by subpart E of 21 CFR Part 507.
d) The written recall plan as required by 21 CFR 507.38(a)(1).
e) The written procedures for monitoring the implementation of the preventive controls as required by 21 CFR 507.40(a).
f) The written corrective action procedures as required by 21 CFR 507.42(a)(1).
g) The written verification procedures as required by 21 CFR 507.49(b).
Specifically, you told the FDA Investigator that you did not have a food safety plan, although you and your PCQI have begun to develop one.
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, the FDA Investigator noted evidence of significant violations of these requirements, which included but were not limited to the following:
2. Your firm failed to evaluate and use raw materials and other ingredients susceptible to contamination with mycotoxins or other natural toxins in a manner that does not result in animal food that can cause injury or illness to animals or humans, as required by 21 CFR 507.25(b)(2).
Specifically, you do not have procedures or conduct testing to determine whether mycotoxins such as aflatoxin, fumonisin, or deoxynivalenol (DON) are present in the grains and grain coproducts that you receive and use in your products. Your facility produces animal food for multiple species, including horses, poultry, deer, sheep, goats, rabbits, cattle, and swine, all of which are known to be negatively affected by mycotoxins. The primary components of your animal foods are grains and grain co-products, which are susceptible to mycotoxin contamination.
Furthermore, we found no evidence that you had evaluated whether your firm was the cause of the fumonisin level above FDA’s recommended 1 ppm limit in finished animal food for equids,5 reported to you on October 29, 2021, by the Office of the Texas State Chemist (b)(4). In addition, you did not evaluate the potential for contamination in other products using the same corn ingredients.
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
- 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 Dana Lewis, Compliance Officer, U.S. Food and Drug Administration at the following email: firstname.lastname@example.org (preferred) or you may mail a hard copy, addressed to Dana Lewis, Compliance Officer, U.S. Food and Drug Administration at 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any further questions, please contact me at 214-253-5205 or by email.
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
Cc: Mary Sasser, Program Director
Office of the Texas State Chemist
445 Agronomy Road
College Station, Texas 77843
1 Fumonisin is a mycotoxin produced by fungi that can contaminate corn and corn products.
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(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 “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.