- Delivery Method:
- VIA Electronic Mail
- Reference #:
- Animal & Veterinary
- Issuing Office:
- Division of Human and Animal Food Operations East IV
Dear Mr. Larson and Ms. Laskin:
The United States Food and Drug Administration (FDA) inspected your non-licensed medicated and non-medicated feed mill located at 1901 NW 9th Street in Okeechobee, Florida, where you produce feeds for beef and dairy cattle, on December 13, 14, and 20, 2021.
The inspection revealed evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation, 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 a prohibited act.2
The 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) is also a prohibited act.3
Additionally, our inspection revealed evidence of significant violations of the requirements for animal feed containing a veterinary feed directive (VFD) drug (VFD feed), Title 21, Code of Federal Regulations, Part 558.6 (21 CFR 558.6). Failure of a facility to comply with the VFD requirements causes the resulting VFD feed to be unsafe within the meaning of the FD&C Act.4 A drug is adulterated if it is an animal feed bearing or containing a new animal drug and the animal feed is unsafe.5
Furthermore, the failure of a facility to follow the VFD requirements causes the VFD feed to no longer be exempt from the requirements that its labeling bear adequate directions for use and as a result, the drug is misbranded under the FD&C Act, if it does not bear adequate directions for use.6 In addition, certain VFD feeds manufactured at your facility are misbranded because its labeling does not identify the drug and its quantity in the VFD feed and fails to include the required cautionary statements.7 8
Finally, our inspection found violations of the Current Good Manufacturing Practice for Medicated Feeds, 21 CFR part 225. Failure of a medicated feed mill to comply with these requirements causes a drug to be adulterated.9
The doing of any act to a food or drug after shipment of the food or drug and/or its components in interstate commerce and while the food or drug is held for sale (whether or not the first sale) that results in the food or drug being adulterated or misbranded is a prohibited act.10
You may find the FD&C Act and FDA’s regulations through links in FDA’s Internet 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 received on January 12, 2022. We have reviewed your responses and we 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 a significant violation of these requirements:
You did not prepare, or have prepared, and did not implement a food safety plan, as required by 21 CFR 507.31(a).
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, your General Manager told the FDA Investigator that you did not have a food safety plan or any of the elements.
We have reviewed your response received January 12, 2022. You stated you have begun researching the correct way to develop a food safety plan. You did not estimate when your food safety plan would be completed and implemented. We encourage you to submit additional documentation related to your food safety plan in follow-up correspondence.
Veterinary Feed Directive (VFD) Requirements
As a VFD distributor, your facility is subject to the VFD requirements found in 21 CFR 558.6. During the inspection of your facility, the FDA Investigator noted that you had distributed animal feed containing a VFD drug that was not labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug, in violation of 21 CFR 558.6(c)(2).11
Specifically, you manufactured (b)(4) Mixed Feed Formula #(b)(4) on 12/10/2021, which was distributed on delivery ticket number (b)(4), dated 12/10/2021. You provided a delivery ticket as labeling which included the addition of "(b)(4)" feed to the formulas for (b)(4) Mixed Feed Formula #(b)(4). The feed delivery ticket included the feed formula, weight of the feed, and the number bags of Aureomycin added to the formula. Per your delivery tickets, you added one (b)(4)lb bag of “(b)(4)” feed (chlortetracycline (b)(4)g/lb.) into the (b)(4) process for every (b)(4) pounds of feed manufactured for formula #(b)(4) under VFD order 21-VFD-17550229. You manufactured and distributed this VFD feed at a concentration of (b)(4) grams/ton of chlortetracycline, which is not an approved combination and is contrary to the (b)(4) grams/ton authorized by the VFD order. Additionally, your accompanying labeling did not contain the VFD drug cautionary statement.12
We have reviewed your response to the most recent FDA inspection, received January 12, 2022. Your response noted (b)(4).” You stated (b)(4).”
We are unable to fully evaluate your response since you did not provide copies of these laminated charts. Such charts would include information such as concentration, time frames for use, and who is responsible for keeping track of the information. Regarding the cautionary language stickers, we recognize that you attached a copy of the stickers to your response. However, you did not supply evidence, such as delivery tickets with the sticker affixed, to support that your corrections have been implemented. We encourage you to submit additional supporting documentation related to your corrective actions in your reply.
Medicated Feed Current Good Manufacturing Practices (CGMP) Requirements
As a non-licensed, medicated feed mill, your facility is required to follow the medicated feed CGMP regulations for non-licensed, medicated animal feed manufacturers found in 21 CFR 225.120-225.202. During the inspection, an FDA Investigator observed evidence of a significant violation of these requirements, which included the following:
You did not receive, handle, and store labels in a manner that prevents label mixups and assures that the correct labels are used for the medicated feed. Under 21 CFR 225.180, all deliveries of medicated feeds, whether bagged or in bulk, shall be adequately labeled to assure that the feed can be properly used.
Specifically, your firm manufacturers (b)(4) Mixed Feed Formula #(b)(4) and (b)(4) Mixed Feed Formula #(b)(4). These formulas are typically non- medicated feeds. When directed, you add (b)(4)) into the (b)(4) process for feed formula #(b)(4) or #(b)(4) in the amount of (b)(4) bag per (b)(4) pounds of feed. You use a “(b)(4)”, which has a unique (b)(4) identifier, as a documentation record and label. The delivery ticket indicates the feed formula and number of bags of (b)(4) that have been added. Delivery ticket number (b)(4) dated 12/10/2021 indicates that you added 4 bags of (b)(4) to formula #(b)(4). However, the delivery ticket does not indicate the dose, feeding instructions, and warnings.
We have reviewed your response to the most recent FDA inspection, received January 12, 2022. Your response noted that a copy of the VFD, with the dosing and duration instructions clearly highlighted, are currently being attached to any delivery ticket for feed with Aureomycin as an ingredient. We are unable to fully evaluate your response since you did not provide any evidence such as a photograph or revised SOP. We encourage you to submit additional supporting documentation related to your corrective actions in your reply.
Current Good Manufacturing Practice 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 a significant violation of these requirements:
You did not 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 in 21 CFR 507.25(b)(2).
Specifically, you have no defined process to manage mycotoxin levels in your grain and grain product ingredients. Grain and grain products are known to be susceptible to mycotoxin contamination. These ingredients are used in your food formulas fed to dairy cows. Dairy cows that consume aflatoxin-contaminated food can transfer toxins to milk, potentially exposing humans to a health hazard.13
We have reviewed your response received January 12, 2022. Your response indicates that you will now “(b)(4).” We are unable to evaluate your response since you did not provide the methodology used to determine the sample size or the frequency of “(b)(4)”, testing from different suppliers, or any procedures for corrective actions in the event of an elevated test result.
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 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”
• Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”
• Draft Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program”
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: Mr. Ramon A. Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. You may email a copy of your response with appropriate attachments to email address: email@example.com. Please ensure your firm name, Firm Establishment Identifier (FEI) and establishment address are included in the correspondence. If you have any questions regarding this letter, please contact Ms. Laura Kennedy, Compliance Officer, at Laura.Kennedy@fda.hhs.gov or (813) 915-7948.
Ramon A. Hernandez
San Juan District Director,
HAFE4 Program Division Director
Office of Human and Animal Food Operations
- 1See 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).
- 2See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
- 3See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].
- 4See Section 512(a)(2) of the FD&C Act [21 U.S.C. § 360b(a)(2)].
- 5See Section 501(a)(6) of the FD&C Act [21 U.S.C. § 351(a)(6)].
- 6See Section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1); see also section 504(a)(1) of the FD&C Act [21 U.S.C. § 354(a)(1)].
- 7See Section 502(c) of the FD&C Act [21 U.S.C. § 352(c)].
- 8See Section 502(e)(1)(A) of the FD&C Act [21 U.S.C. § 352(e)(1)(A)].
- 9See Section 502(a)(2)(B) of the FD&C Act [21 U.S.C. § 351(a)(2)(B)].
- 10See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
- 11See also 21 CFR 558.6(a)(3).
- 12See 21 CFR 558.6(a)(6).
- 13See Chemical Hazards | FDA.