WARNING LETTER
Midwestern Pet Food
MARCS-CMS 613845 —
August 09, 2021
Delivery Method:
Via Email
Product:
Animal & Veterinary
Recipient:
Recipient Name
Jeffrey J. Nunn
Recipient Title
President, CEO, Co-Owner
Midwestern Pet Food
9634 Hedden Rd.
Evansville
,
IN
47725
United States
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
FY21-HAFE6-04
August 9, 2021
FEI: 3013408830
Dear Jeffrey J. Nunn:
The United States Food and Drug Administration (FDA), along with the Oklahoma Department of Agriculture, inspected your pet food manufacturing facility located at 913 N 9th Street, Chickasha, OK 73018 (OK) between the dates of December 31, 2020 and February 5, 2021. This inspection was conducted in response to a voluntary Class I recall of approximately 19 products initiated by your firm on December 30, 2020 and expanded on January 11, 2021 due to the presence of the potentially deadly hazard of aflatoxin and as a follow-up to numerous consumer complaints of suspected mycotoxin poisoning leading to pet illness and/or death. Following the receipt of the first complaints on December 29, 2020, the Missouri Department of Agriculture collected and analyzed samples of your product “SPORTMiX High Energy Dog Food” with expiration dates of February 6, 2022 and March 3, 2022 for the presence of mycotoxins. Analytical results identified elevated levels of aflatoxin above 20 parts per billion (ppb). The Office of the Texas State Chemist and the FDA collected additional samples. Analysis of these subsequent samples found that additional SPORTMiX branded products, spanning multiple products and lot codes, contained aflatoxin at levels as high as 558 ppb. FDA considers that aflatoxin levels in dog and cat food above 20 ppb will support a charge of adulteration under section 402(a)(1) of the FD&C Act [21 U.S.C. § 342(a)(1)] because of the reasonable possibility that a regular diet of such food will be fatal or injurious to the health of the pet. Therefore, these pet food products manufactured in your OK facility are adulterated in that they bear or contain a poisonous or deleterious substance which renders them injurious to health.
FDA initiated additional site inspections of your pet food manufacturing facilities located at:
702 Broad Street Extension, Waverly, NY 14892 (NY) between the dates of February 9, 2021 and February 23, 2021.
9634 Hedden Road, Evansville, IN 47725 (IN) between the dates of February 1, 2021 and March 3, 2021.
617 South D Street, Monmouth, IL 61462 (IL) between the dates of February 2, 2021 and April 16, 2021.
During the IL inspection, you recalled approximately 104 products of dry dog and cat diets made in your IL facility from October 26, 2020 - November 12, 2020, February 1, 2021 - February 12, 2021, and March 15, 2021 - March 19, 2021, because your routine monitoring yielded
Salmonella
-positive results for pet diets manufactured on common equipment during those periods.
During the inspections at your facilities, FDA investigators found 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). Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is prohibited by section 301(uu) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. § 331(uu)]. The criteria and definitions in 21 CFR Part 507 apply in determining whether an animal food is adulterated within the meaning of section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. (See 21 CFR 507.1(a)(1)(ii))
The introduction or delivery for introduction into interstate commerce of an adulterated food is a prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. 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 each inspection, you or your plant manager was issued a Form FDA 483, Inspectional Observations. We acknowledge you
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have provided written Form FDA 483 responses dated February 25, 2021 (OK), March 12, 2021 (NY), March 19, 2021 (IN), March 30, 2021 (IL), and May 6, 2021 (IL) describing corrective actions you have taken or plan to take to address the observations at each of your facilities. We have reviewed your responses and we address your corrective actions below.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facilities are 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 inspections of your four facilities, FDA Investigators noted evidence of significant violations of these requirements, which included but were not limited to the following:
1. You did not identify or implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the FD&C Act, as required by 21 CFR 507.34(a)(1).
Mycotoxins in Grain/Grain Meals
Your written food safety plan (FSP) hazard analyses (HA) for the OK, NY, IN, IL facilities identified the known or reasonably foreseeable hazard of aflatoxin in incoming corn and corn products as a hazard requiring a preventive control. According to each FSP, your preventive control is “Aflatoxin inhouse testing” with an acceptance parameter for aflatoxin in corn and corn products at receiving
(b)(4)
, with any incoming corn or corn products
(b)(4)
or greater to be rejected. However, your facilities failed to follow proper sample preparation procedures, as outlined in the aflatoxin test kit manufacturer’s recommended procedure, referenced USDA Mycotoxin Handbook, and/or facility-defined procedures that your facilities reported as being followed. This led to potentially inaccurate analyses and test results for sampled products.
Failure to implement the preventive control was further evidenced by sixteen samples of your OK facility’s finished SPORTMiX cat and dog food products collected by FDA and State counterparts. These samples were found to contain elevated levels of aflatoxin from 21.5 ppb to 558 ppb, levels that FDA has determined to be harmful in dog and cat food, as noted above.
The preventive control you established to control the aflatoxin hazard at your facilities was not properly implemented and therefore was ineffective at significantly minimizing or preventing the hazard of aflatoxin and did not provide assurance that the pet food manufactured at your facility will not be adulterated.
Salmonella Recontamination
Your written FSP HAs for your OK, NY, IN, and IL facilities determined that the known or reasonably foreseeable hazard of
Salmonella spp
. in
(b)(4)
made of
(b)(4)
is a hazard requiring a preventive control. The
(b)(4)
, which is identified
(b)(4)
controlling
Salmonella spp
. in ingredients at the product
(b)(4)
. Your FSPs identify your
(b)(4)
(i.e., portions of a
Salmonella
-positive lot undergo additional testing
(b)(4)
for
(b)(4)
.
For example, you collected samples from the following nine lots of finished pet food products manufactured at your IL facility between
(b)(4)
:
• SPORTMiX 24/20 Energy Plus
(b)(4)
, lot 0304282022
• SPORTMiX Gourmet Mix Cat Food
(b)(4)
, lot 0305022022
• Earthborn Coastal Catch
(b)(4)
, lot 0305032022
• Earthborn Large Breed
(b)(4)
, lot 0305042022
• Earthborn Coastal Catch
(b)(4)
, lot 0305042022
• Earthborn Meadow Feast
(b)(4)
, lot 0305092022
• Earthborn Wild Sea Catch
(b)(4)
, lot 0308092022
• Earthborn Coastal Catch
(b)(4)
, lot 0308042022
• SPORTMiX 24/20 Energy Plus
(b)(4)
, lot 0309162022
In-house analysis found these samples to be presumptively
Salmonella
-positive and they were subsequently confirmed positive by your third-party laboratory. However, under your
(b)(4)
control, you distributed into interstate commerce portions of the following
Salmonella
-positive pet food lots:
• SPORTMiX 24/20 Energy Plus
(b)(4)
, lot 0304282022
• SPORTMiX Gourmet Mix Cat Food
(b)(4)
, lot 0305022022
• Earthborn Coastal Catch
(b)(4)
, lot 0305032022
• Earthborn Large Breed
(b)(4)
, lot 0305042022
• Earthborn Coastal Catch
(b)(4)
, lot 0305042022
• Earthborn Meadow Feast
(b)(4)
, lot 0305092022
• Earthborn Coastal Catch
(b)(4)
, lot 0308042022
A
(b)(4)
does not control the
Salmonella
hazard in the liquid outside coatings (although testing can provide verification that a preventive control adequately controls a hazard, as established in 21 CFR 507.49).
Therefore, you failed to implement a preventive control to provide assurance that the Salmonella spp. hazard is significantly minimized or prevented and that the pet food manufactured at your facilities will not be adulterated.
General evaluation of your responses and corrective actions:
We acknowledge your voluntary recalls of adulterated product contaminated with aflatoxin and Salmonella. However, recalling product does not prevent the reoccurrence of a hazard in your pet food. It is your responsibility to prevent adulterated product from entering the animal food supply through a robust hazard analysis and risk-based preventive controls program. You have not provided documentation showing that you have adequately implemented your preventive control for mycotoxins that will significantly minimize or prevent this hazard. You also have not provided documentation showing that you have adequately implemented preventive controls for Salmonella to prevent the recontamination of product
(b)(4)
from reoccurring at your IL facility or occurring at your other three facilities. Therefore, we are unable to fully assess your corrective actions. This is detailed in the two sections that follow.
Below we discuss specific points regarding your responses and corrective actions, as described in your responses to the Form FDA 483 provided for each of your four pet food manufacturing facilities.
Evaluation of your Mycotoxin response:
You stated in your responses that you would be revising your sample collection, preparation, and analysis procedures to address the hazard of aflatoxin. You provided a detailed summary of the changes which you state will be standardized across all four facilities for incoming corn, wheat, barley, oats, and rice. However, your responses do not include sufficient information and supporting documentation for us to fully assess the changes. For example, it is unclear if you have provided employee training on the new aflatoxin test procedures or if you have begun utilizing the new aflatoxin test procedures, as no employee training records or test records demonstrating implementation of the new test procedures were included with your responses.
In addition, your February 25, 2021 (OK) response stated you will be implementing a
(b)(4)
aflatoxin testing in all finished product batches containing corn prior to their release at your OK facility. However, you did not state in your responses for NY, IN, and IL that you would also be implementing the
(b)(4)
as a verification activity for these facilities nor did you provide the written
(b)(4)
for our review of its adequacy. Your response also does not address the use of this
(b)(4)
activity in your facilities for products that contain, as applicable, wheat, barley, oats, rice, and their by-products.
Finally, your May 6, 2021 (IL) response states that you have standardized your aflatoxin procedures across all of your facilities and have migrated to the use of
(b)(4)
for aflatoxin test using the
(b)(4)
in all of your facilities for incoming corn, wheat, barley, oats, and rice upon receipt. However, you did not submit examples of completed records of sample collection, preparation, and analysis as evidence that the procedures have been implemented.
As a result of a lack of submitted supporting documentation, we are unable to evaluate your corrective actions.
Evaluation of your
Salmonella
response:
In your February 25, 2021 (OK), March 12, 2021 (NY), March 19, 2021 (IN), March 30, 2021 (IL) responses, you indicate that you will implement
(b)(4)
at each facility that will involve a
(b)(4)
for fats, oils, and liquid digests used
(b)(4)
. You appear to be describing a
(b)(4)
control (21 CFR part 507, subpart E). You did not provide revised FSPs or implementation records, so we are unable to evaluate this corrective action.
In your responses, you indicate you will be implementing
(b)(4)
at each facility. This appears to involve the development of “enhanced cleaning procedures” and sanitation standard operating procedures (SOPs). In your May 6, 2021 (IL) follow-up letter, you stated that other priorities have delayed completion of the sanitation SOPs. We have not received documentation regarding your enhanced cleaning procedures, the sanitation SOPs
(b)(4)
, or records of implementation at any of your facilities, so we are unable to evaluate this corrective action.
In your May 6, 2021 (IL) response, you indicated that, with expert assistance, you shut down and cleaned your IL facility (which had manufactured the
Salmonella
-positive pet food), followed by environmental swabbing and repeat cleaning in an effort to eliminate
Salmonella
harborage sites. You stated that the same expert is guiding your IL facility through a root cause investigation.
Your May 6, 2021 (IL) response further states that your root cause analysis showed that it was “extremely unlikely” that
Salmonella
-positive product would contaminate other products subsequently manufactured on the same equipment because there is no moisture associated with the equipment, and, accordingly,
Salmonella
cannot grow on the equipment or in the product. You further stated that you believe product contamination “likely occurred” sporadically as a result of maintenance activity or other human-related activity on the line, and not from any systematic source of contamination. You have not provided your root cause analysis that includes a full description of the areas of your operation that were evaluated and what the findings of those evaluations were. Therefore, it is unclear if the root cause of the
Salmonella
contamination identified any specific
Salmonella
niche or harborage areas in your facility.
Additionally, your statement that there is no moisture on the equipment is not consistent with your own findings. You found moisture inside the enclosed
(b)(4)
conveyance equipment on
(b)(4)
. You reported during the inspection this was a result of water condensate dripping down the interior of the tube into the boot of the drag conveyor. It is unclear if you have fully resolved the moisture issue or if you evaluated other enclosed
(b)(4)
conveyance lines to see if a similar problem exists.
Your two IL facility responses did not include sufficient information and supporting documentation for us to fully assess your response to the
Salmonella
contamination. Documents referenced in your response that have not been submitted to FDA include the following:
• supporting documentation or a detailed description of the root cause investigation.
• supporting documentation or a detailed description of expert advice regarding the IL facility’s corrective actions, protocols, and procedures.
• sanitation records documenting repeated thorough cleanings of the facility.
In your May 6, 2021 (IL) response, you indicated that the new sampling plan and test method version of your
(b)(4)
for
Salmonella
was significantly more likely to identify a
Salmonella
positive lot than the previous plan, in that it will provide a more representative sample of the lot and will test larger amounts of product. You also acknowledge that your
(b)(4)
is not a preventive control, but a
(b)(4)
(see 21 CFR 507.49), presumably for the new supply-chain program preventive controls and sanitation preventive controls you stated you are implementing at your facilities. The most recent FSP was provided by you during the IL facility inspection on February 3, 2021 with an effective date of January 29, 2021. This FSP includes the
(b)(4)
you identified as
(b)(4)
Control:
(b)(4)
for
Salmonella spp
. at various process steps. You have not provided revised FSPs for your four facilities reflecting the removal of the
(b)(4)
as a preventive control, written procedures for the finished product sampling plan, nor have you provided the
(b)(4)
product sampling results. Therefore, we are unable to evaluate your corrective actions regarding your
(b)(4)
.
We will verify the adequacy and implementation of your proposed corrective actions during follow up inspections.
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).
Specifically, your OK, IN, and IL facilities receive, as incoming ingredients for use in the manufacturing of pet foods, grains or grain by-products, including corn, wheat, and barley, that are susceptible to vomitoxin and/or fumonisin mycotoxin hazards. You did not identify and evaluate vomitoxin and fumonisin hazards in your HAs. However, you reported these mycotoxins were being assayed in susceptible incoming grains and grain by-products. We note that your NY facility had recently revised their HA on January 18, 2021 to include vomitoxin and fumonisin hazards for incoming corn, wheat, and barley ingredients and had just started routinely documenting the test results. However, prior to this revision your NY facility was operating similarly to the OK, IN, and IL facilities, in that vomitoxin and fumonisin were not identified or evaluated in the HA as a known or reasonably foreseeable mycotoxin hazard requiring a preventive control.
We acknowledge you have provided written responses to the Form FDA 483 for each facility describing corrective actions you have taken or plan to take to address this observation. Specifically, your responses acknowledge that the testing and the associated HA were not previously reflected in your FSPs. You further state that you are in the process of reanalyzing your IL and IN FSPs to include a HA for the presence of fumonisin and vomitoxin and to document the analysis related to these hazards.
(b)(4)
. Your responses state that your NY and OK facilities have reanalyzed their FSPs such that they now include HAs for fumonisin and vomitoxin hazards. Analytical SOPs, including onsite training from the manufacturer, were estimated as being completed by
(b)(4)
.
Your responses for all facilities lacked any examples of completed records to support your corrections including the analytical SOP, documentation of onsite training from the test manufacturer, the reanalysis of your FSPs, and analytical results of testing of incoming product since initiating your corrections at all facilities. Without the updated HAs, corresponding SOPs, and resulting assay documentation, we are unable to evaluate your corrective actions. We will verify the adequacy and implementation of your proposed corrective actions during follow up inspections.
3. At your NY and IN manufacturing facilities you have determined that contamination of an animal food with an environmental pathogen is a hazard requiring a preventive control. However, you failed to verify that your preventive control is consistently implemented and is effectively and significantly minimizing or preventing the hazard through environmental monitoring, as required by 21 CFR 507.49(a)(3).
Specifically, your
(b)(4)
activities include an “Environmental Monitoring SOP.” Your SOP for your IN facility, entitled “
(b)(4)
,” dated September 7, 2018, states a minimum
(b)(4)
must be performed across
(b)(4)
Area and Packing on
(b)(4)
basis. Your protocol also states a minimum
(b)(4)
shall be collected on
(b)(4)
basis. During the IN facility inspection, it was observed that you swabbed
(b)(4)
sites from zones
(b)(4)
on
(b)(4)
basis, and of those, only a portion were collected across
(b)(4)
Area and Packing, while no additional
(b)(4)
sampling was documented as being conducted.
Furthermore, your environmental monitoring SOP for your NY facility, dated January 19, 2021, identifies the corrective actions for in-house presumptive positives to include recleaning and sanitizing of the presumptive positive areas, followed by
(b)(4)
until negative results are achieved on
(b)(4)
consecutive swabbing episodes. At your NY facility, you did not conduct
(b)(4)
that resulted in
(b)(4)
results following an initial positive result
(b)(4)
lots collected between September 4, 2020 and January 13, 2021. Additionally, recleaning and sanitizing was not documented as occurring for four of those same lots.
Your responses dated March 12, 2021 (NY) and March 19, 2021 (IN), describe corrective actions you have taken or plan to take to address this observation. Your responses state the
(b)(4)
has been re-assessed to ensure it is able to better verify the end of week Master Cleaning Schedule in
(b)(4)
areas and will focus on high risk areas. In addition, your responses state that as the sanitation control program is developed and sanitation SOPs are implemented, the
(b)(4)
will again be re-assessed to ensure it serves as an effective verification to cleaning activities.
Furthermore, we acknowledge receipt of your written response dated May 6, 2021 (IL) which states you will now be sampling on various days during the week and will not sample only following
(b)(4)
cleaning and sanitation. You further indicate that you will continue conducting environmental monitoring for Salmonella as a verification procedure for your
(b)(4)
cleaning events. However, it is unclear whether the corrections stated will be implemented across all manufacturing facilities.
Your IN, NY, and IL responses to the Form FDA 483 did not include any documentation to support your corrections, including the assessment report for the
(b)(4)
, the sanitation control program, and corresponding sanitation SOPs. Your responses also do not include examples of completed records of enhanced cleaning procedures for
(b)(4)
processing equipment and environmental monitoring for
Salmonella
in your facilities as a verification activity to demonstrate the sanitation preventive control has been adequately implemented. Therefore, we are unable to evaluate the adequacy and implementation of your proposed corrective actions. We will verify the adequacy and implementation of your proposed corrective actions during follow up inspections at these locations.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facilities 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 facilities 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. 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”,
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 within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Please send your firm’s response to Darren S. Morgan, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have questions regarding any issues in this letter, please contact Mr. Morgan at darren.morgan@fda.hhs.gov or 313-393-8149.
Sincerely,
/S/
Michael Dutcher, DVM
Acting Director of Compliance
Division of Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
William R. Weissinger, MS
District Director | FDA Chicago District
Program Division Director
Office of Human and Animal Food Operations East – Division 6
CC:
Dylan R. Woods, Plant Manager
Midwestern Pet Foods Inc.
913 North 9th St.
Chickasha, OK 73018-1817
Nino R. D'Angelo, Plant Manager
Midwestern Pet Foods, Inc.
702 Broad Street Ext
Waverly, NY 14892-9562
Michael G. Sheid, Plant Manager,
Midwestern Pet Foods, Inc.
617 S. D Street
Monmouth, IL 61457-2157
Richard J. Nunn, Vice-President/Co-Owner
Midwestern Pet Foods, Inc.
9634 Hedden Road
Evansville, IN 47725-9660
Office of the Texas State Chemist
Dr. Timothy Herrman
445 Agronomy Road
College Station, TX 77843
Oklahoma Department of Agriculture, Food and Forestry
Cody Walls, Feed Program Administrator CPS Division
2800 N. Lincoln Blvd.
Oklahoma City, OK 73105
Missouri Department of Agriculture
Stan Cook, Program Manager, Bureau of Feed and Seed
1616 Missouri Boulevard
Jefferson City, Missouri 65102
______________________________
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Each response was provided by your legal counsel on behalf of Midwestern Pet Foods, Inc.
Content current as of:
08/17/2021
Regulated Product(s)
Animal & Veterinary