WARNING LETTER
Best Buy Bones, Inc.
MARCS-CMS 719212 —
April 30, 2026
Delivery Method:
VIA EMAIL NO HARD COPY TO FOLLOW
Product:
Animal & Veterinary
Recipient:
Recipient Name
Arnold McIntyre/Delbert J. McCord
Recipient Title
Part Owners
Best Buy Bones, Inc.
7426 N Dort Hwy
Mount Morris
,
MI
48458-2232
United States
arnoldmcintyre@bestbuybones.com
Issuing Office:
Office of Surveillance and Compliance
United States
Secondary Issuing Offices
United States
April 30, 2026
WARNING LETTER
Dear Messrs McIntyre and McCord,
The U.S. Food and Drug Administration (FDA) conducted an inspection of your pet food manufacturing facility, located at 7426 N Dort Hwy, Mount Morris, Michigan, from September 8 through September 12, 2025. We have received and evaluated your written responses, dated October 3, 2025, and February 4, 2026, to the Form FDA 483, Inspectional Observations (FDA 483), issued at the close of inspection.
During the inspection, an FDA investigator found evidence of significant violations of FDA’s 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). These violations cause your products to be adulterated under the Federal Food, Drug, and Cosmetic Act (the Act), in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
1
The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.
2
Also, 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 of Part 507) is a prohibited act.
3
During the inspection, on September 9, 2025, an FDA investigator collected samples of your Nature's Own Pet Chews Bully Bites, lot 9/2027. Sample analysis revealed that the sampled lot contained
Salmonella Uganda
. Therefore, your Nature's Own Pet Chews Bully Bites, lot 9/2027, are adulterated under the Act in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.
4
Your firm initiated a voluntary recall of certain lots of Nature’s Own Pet Chews Bully Bites on October 1, 2025.
You may find the Act and FDA’s regulations through links in FDA’s homepage at www.fda.gov.
At the close of the inspection, you were issued a form FDA 483, Inspectional Observations. As noted above, we received your written responses, dated October 3, 2025, and February 4, 2026. We have reviewed your responses, and we discuss your corrective actions below in relation to each of the noted violations.
Hazard Analysis and Risk-Based Preventive Controls Requirements
During our inspection of your facility, the FDA investigator observed evidence of significant violations of the Hazard Analysis and Risk-Based Preventive Controls requirements found in 21 CFR part 507, subparts A, C, D, E, and F including the following:
1. You did not determine and conduct appropriate supplier verification activities and satisfy all documentation requirements, as required by 21 CFR 507.115(a)(2).
For your written “Preventive Control #1 - Supply Chain Program for Potential Biological Hazards (Salmonella and E-Coli) of Ready to Eat Product” (Preventive Control #1) you determined the required supplier verification activities would include reviewing Certificates of Analysis (COA),
(b)(4)
laboratory testing of product to verify the COA, completion of supplier approval questionnaires, and review of records for third-party audits. However, these required supplier verification activities are not consistently performed or not conducted at all.
For example, you are not conducting the following supplier verification activities for your supply-chain-applied control:
(b)(4)
lab testing of products to verify the COAs, requiring firms to fill out a supplier questionnaire, and annual review of records for third-party audits.
Additionally, your Preventive Control #1 requires COAs from your ready-to-eat (RTE) suppliers and review of the COAs by management; however, you are only collecting and reviewing COAs from two of your
(b)(4)
current RTE suppliers (specifically, you did not collect and review COAs from your bully stick supplier).
Furthermore, unless there is a written determination otherwise, when a supply-chain applied control is used for a hazard for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (SAHCODHA), the appropriate supplier verification activity is an annual onsite audit of the supplier, as required by 21 CFR 507.130(b).
Salmonella
and
E. coli
are hazards with the reasonable probability to cause SAHCODHA. However, your “Ready to Eat, Tissue, Bone, Flavoring and Packaging Product Receiving” procedures do not require annual onsite audits, and you do not have a written justification for accepting other verification activities in lieu of an annual onsite audit at your suppliers.
Evaluation of your responses:
Your written response, dated October 3, 2025, outlined several corrective actions, including re-implementing
(b)(4)
laboratory testing, with samples sent to a laboratory on
(b)(4)
; sending supplier questionnaires to suppliers on
(b)(4)
; and investigating whether suppliers have third-party certification. You also scheduled a consultant visit for
(b)(4)
, to review your supply chain program.
Although you stated in your response that you have investigated whether your suppliers were part of a third-party certification program, your responses do not include a procedure for conducting annual onsite audits, or reviewing annual onsite audits conducted by a third-party certification program. If the frequency of onsite audits is less than annually, you will continue to need written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled. Your responses also lack supporting documentation demonstrating that you are now receiving COAs from your bully stick supplier or other current RTE product suppliers. Therefore, we are unable to fully evaluate the adequacy of your corrective actions.
2. You did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control are 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).  For example:
a. You failed to adequately implement minimum temperature and time controls directed by your Food Safety Plan and/or “cookbook.”
i. One batch of chicken feet produced in oven
(b)(4)
between
(b)(4)
, and
(b)(4)
, did not reach the minimum time and temperature directed by your Food Safety Plan (SOP FSP-30), which directs the operator to set the oven temperature and time according to your “cookbook.” The cooking profiles are copied from the cookbook onto the corresponding Raw Product Detail form, which indicates that chicken feet are to be cooked at
(b)(4)
°F for
(b)(4)
hours,
(b)(4)
°F for
(b)(4)
hours,
(b)(4)
°F for
(b)(4)
hours, and then
(b)(4)
°F for
(b)(4)
hours. However, the temperature monitoring graph for chicken feet produced in oven
(b)(4)
between
(b)(4)
, and
(b)(4)
, indicates the oven failed to meet the required
(b)(4)
°F for
(b)(4)
hours and the required
(b)(4)
°F for
(b)(4)
hours.
ii. Two batches of duck feet produced in ovens
(b)(4)
and
(b)(4)
between
(b)(4)
, and
(b)(4)
, did not reach the minimum temperature and time indicated on the corresponding Raw Product Detail forms. Based on the information provided on the Raw Product Detail forms, your duck feet are to be cooked at
(b)(4)
°F for
(b)(4)
hours, then
(b)(4)
°F for
(b)(4)
minutes. However, temperature monitoring graphs for duck feet produced in ovens
(b)(4)
and
(b)(4)
between
(b)(4)
, and
(b)(4)
, indicate these ovens failed to meet the required
(b)(4)
°F for
(b)(4)
hours.
Additionally, we note that the inspection revealed that your Preventive Controls Qualified Individual (PCQI) (or an individual under the oversight of your PCQI) had not reviewed the monitoring records for the above-mentioned batches of duck and chicken feet to verify that the required time and temperature parameters for your preventive control were met, as required by 21 CFR 507.49(a)(4)(i).
b. In addition, your hazard analysis identifies a sanitation preventive control for the biological hazards of
Salmonella
and
E. coli
(b)(4)
for your bone and tissue pet treats and chews; however, you failed to adequately implement your sanitation preventive control.
i. Your sanitation procedure, “FSP-5, Sanitation Standard Operating Procedure’s (SSOP’s),” establishes standards and procedures to follow when cleaning and sanitizing activities are being performed. The procedure states: “
(b)(4)
.” The sanitizer is in a
(b)(4)
form that is
(b)(4)
.
During the inspection, an employee was observed filling the
(b)(4)
with the
(b)(4)
sanitizer. When the employee attempted to verify the concentration of the
(b)(4)
sanitizer, they used a
(b)(4)
instead of a
(b)(4)
because
(b)(4)
were not available.
Additionally, your firm uses spray bottles containing a
(b)(4)
solution on food contact surfaces in the
(b)(4)
Room and
(b)(4)
Room. According to the “Sanitizing / Disinfecting Mixture Sign-off” form for each room, the sanitizer is
(b)(4)
following the provided formulation and the concentration verified using
(b)(4)
. However,
(b)(4)
solution concentrations were not recorded for at least the month of August 2025 on the “Sanitizing / Disinfecting Mixture Sign-off” record for the
(b)(4)
Room.
ii. Your “Production Area Cleaning and Sanitation Log” does not include all equipment and utensils that need to be cleaned and sanitized. For example, your log does not include the
(b)(4)
totes,
(b)(4)
bins, or
(b)(4)
containers used to store RTE products. During the inspection, these totes, bins, and containers were observed in the processing room holding RTE products.
iii. Your written “Environmental Monitoring Procedures SOP” establishes environmental monitoring procedures for your pet treat facility and includes a “corrective action” section that requires that you “[e]stablish action limits for each zone and organism.” The SOP further lists additional procedures to follow (such as “increase sampling frequency in affected areas”) when those limits are exceeded. Your firm failed to establish action limits for each zone and organism as required by your Environmental Monitoring Procedures SOP. Further, because you failed to establish action limits, you are unable to determine when such limits are exceeded and therefore whether the additional procedures listed in your SOP must be followed.
Evaluation of your responses:
Your written response, dated October 3, 2025, outlined the root cause and corrective actions related to your process preventive control cook times and temperatures. You indicated that the root cause for product not reaching required time and temperature for your preventive control was due to not having established minimum operational cook times and temperatures in your Food Safety Plan, and that you need to account for variance in temperature monitors and temperature ramp times that can alter operating minimums. You indicated that you have now established minimum operational cook times and temperatures for all products in your Food Safety Plan. However, we are unable to evaluate the adequacy of your corrective actions because you have not provided supporting documentation to demonstrate that you are consistently and adequately implementing your corrective actions.  For instance, you have not provided a copy of your revised Food Safety Plan and applicable monitoring records.
Additionally, your October 3, 2025, response indicated you have assigned review of monitoring records to a qualified person who will review records within required timeframes and that you have developed a list of records that are required to be reviewed. We are unable to evaluate the adequacy of this corrective action because you did not provide any supporting documentation.
Your written responses also outlined corrective actions related to your sanitation preventive control, including employee retraining on proper sanitizer mixing and recording, addition of missing equipment to cleaning and sanitation logs, and implementation of a monitoring program to ensure your PCQI reviews are conducted as required. In addition, your written response dated February 4, 2026, states that you have implemented action limits for
(b)(4)
Salmonella
, and
E. coli
. We are unable to fully evaluate the adequacy of your corrective actions related to your sanitation preventive control because you did not provide supporting documentation to demonstrate that your corrective actions have been consistently and adequately implemented.
3. Your firm failed to document the monitoring of preventive controls, as required by 21 CFR 507.40(c)(1). “Monitor” means to conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended.
5
a. You do not document the cooking times and temperatures for products that are
(b)(4)
. For example, you were not able to supply documentation for your Naked Small Kneecaps dated
(b)(4)
, labeled "
(b)(4)
," and your Naked Marrow dated
(b)(4)
, labeled "
(b)(4)
," to show that they were
(b)(4)
for the appropriate cooking time and temperatures. You stated during the inspection that you do not document the time and temperatures of products that are
(b)(4)
.
b. Your “Metal Detection SOP” requires employees to run
(b)(4)
pet treat products through the metal detector
(b)(4)
. However, on
(b)(4)
, you did not completely fill out your “Metal Detection Test Log.” Specifically, for two of the
(b)(4)
products tested, you did not record the product lot code, pass/fail result, or the initials of the employee conducting the monitoring.
Evaluation of your responses:
Your written response, dated October 3, 2025, identified corrective actions, including updating policies to require documentation of
(b)(4)
times and temperatures when used as corrective actions, and retraining employees on proper completion of metal detection logs. You also stated at the close of the inspection that you plan to collect all forms by
(b)(4)
for review and will provide training to employees on updated procedures. We are unable to fully evaluate the adequacy of your corrective actions because you did not provide any supporting documentation, such as updated policies and training logs.
4. You did not establish and implement appropriate written corrective action procedures for your process preventive control, as required by 21 CFR 507.42(a)(1).
Your firm did not implement corrective actions when your established critical temperature limit for cooking was not met for the required time period. For instance, from
(b)(4)
through
(b)(4)
, two batches of duck feet did not reach your prescribed parameters of
(b)(4)
° F for
(b)(4)
hours. From
(b)(4)
, through
(b)(4)
, one batch of chicken feet did not meet your prescribed parameters of
(b)(4)
° F for
(b)(4)
hours,
(b)(4)
° F for
(b)(4)
hours,
(b)(4)
° F for
(b)(4)
hours, and
(b)(4)
° F for
(b)(4)
hours.  You did not conduct any corrective actions in response to the above deviations.
Evaluation of your responses:
At the close of the inspection, you indicated you will begin recording corrective actions and will make them more standardized so that employees have a format to follow. You also indicated that you planned to ensure uniformity so that every product report contains the same information, and you mentioned adding a section for corrective actions to the same document that contains the cooking information for your products. In your written response, dated October 3, 2025, you stated that you have established minimum cooking times and temperatures for all products in the Food Safety Plan and updated your preventive controls corrective actions to include greater detail to prevent recurrence and to describe how the product should be handled or disposed of. However, we are unable to fully evaluate the adequacy of your corrective actions because you did not provide supporting documentation, such as a revised Food Safety Plan, demonstrating that you have established minimum cooking times and temperatures, and supporting documentation demonstrating that you have developed and implemented written corrective action procedures.
5. Your corrective action procedures for preventive controls do not comply with 21 CFR 507.42(a)(2).
Your written corrective actions procedures for your Preventive Control #3 – “Process Preventive Control – Thermal Treatment through the Cooking Process” (Preventive Control #3), do not adequately describe the steps to follow to ensure appropriate corrective action is taken. Your Preventive Control #3 describes 3 corrective actions to take: identifying the root cause, providing retraining as needed, and making repairs to equipment as needed. These corrective action procedures, however, do not comply with 21 CFR 507.42(a)(2)(i)–(iv), because they do not describe in detail the steps to take to ensure that appropriate action is taken to correct a problem that has occurred with the implementation of a preventive control, appropriate action is taken when necessary to reduce the likelihood the problem will recur, how you will evaluate the safety of all affected animal food, and how you will ensure that all affected animal food is prevented from entering commerce if you cannot ensure that the affected animal food is not adulterated under section 402 of the FD&C Act.
Evaluation of your responses:
Your written response, dated October 3, 2025, stated that you have updated the corrective actions in your Food Safety Plan’s preventive controls; however, we are unable to evaluate the adequacy of this corrective action because you did not include a copy of the changes to your Food Safety Plan or provide details about the changes made to your corrective action procedures.
6. Your written environmental monitoring procedures do not identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring, as required by 21 CFR 507.49(b)(3)(iii).
Your “Environmental Monitoring SOP” (FSP-016) does not identify the specific locations from which samples will be collected and the number of sites to be tested. An effective environmental monitoring program diligently tries to find the pathogen. To be effective, sampling should be conducted with sufficient frequency and samples should be taken in places in the facility where the pathogen is likely to be found, such as areas that may have been contaminated with raw animal food ingredients, or areas that are frequently wet.
Evaluation of your responses:
Your written response, dated February 4, 2026, included an updated Environmental Monitoring SOP and floor plan. This updated procedure divides your firm’s environment into
(b)(4)
zones based on their
(b)(4)
, and these zones are reflected on the provided floor plan. The updated SOP also states that environmental samples are
(b)(4)
selected from within these zones and that swabs are analyzed for specific organisms based on the zone sampled. The updated SOP, however, does not identify the number of sites to be tested during routine environmental monitoring. Further, you have not provided supporting documentation to demonstrate the procedure has been implemented. Therefore, we are unable to fully evaluate the adequacy of your corrective actions.
Current Good Manufacturing Practice (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 observed that 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).
The FDA investigator observed manufacturing operations in your
(b)(4)
and
(b)(4)
Rooms on September 8, 2025, through September 11, 2025. On September 9, 2025, an employee was observed dropping two pieces of Nature’s Own Pet Chews smoked “naked” cow ears, lot
(b)(4)
, onto the floor, then picked them up with their gloved hands and placed them into the retail package. The employee then continued to pack the retail boxes without changing their gloves. Unpackaged finished product that has fallen on the ground and placed with other unpackaged finished product can lead to contamination of all finished product. Further, not changing gloves and/or washing hands after handling product that has touched the ground could lead to contamination.
Evaluation of your response:
Your written response, dated October 3, 2025, outlined corrective actions, including employee training in food safety sanitation practices and principles, and drafting of a plant sanitation inspection process to be reviewed with your consultant on October 14, 2025. We will review the adequacy of your corrective actions during our next inspection.
Conclusion
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.
We also have the following comment:
FDA conducted a review of your validation study for beef bone thermal treatment. Our review determined that the study does not provide sufficient evidence that your thermal treatment process can significantly reduce or prevent pathogens in beef bones used for pet treats.  Specifically:
• The review identified several deficiencies for a validation study including: lack of a detailed description of how temperature probes were secured to prevent inaccurate measurements, absence of detailed information about analytical methods used for pathogen testing, failure to indicate whether bones were inoculated with target organisms or provide baseline contamination levels before thermal treatment, and use of an inadequate sample size for an acceptable validation study (i.e., use of
(b)(4)
beef hock as a representative sample size).
• Additionally, our review noted that the internal bone temperature from the representative sample of beef hock did not reach oven temperature even after
(b)(4)
hours of cooking.
• Further, without knowing the initial contamination levels, it cannot be determined whether Salmonella was eliminated by the thermal treatment or if the bones were pathogen-free at the start of the process. A properly designed validation study would require detailed descriptions of bone characteristics, study procedures, sampling methods, analytical techniques, and a sufficient sample size to demonstrate that your thermal treatment provides adequate pathogen reduction in bone marrow.
For more information about FDA’s current thinking on the requirements of 21 CFR Parts 507, 225, and 558, see:
• For Industry | FDA (https://www.fda.gov/animal-veterinary/resources-you/industry)
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 your products are not in violation of the Act and FDA regulations, include your reasoning and any supporting information for our consideration.
The Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any responses you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.
Please direct your electronic correspondence to Compliance Officer Chad Whitwell at Chad.Whitwell@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Chad Whitwell by telephone at (214) 253-5328, or by email at Chad.Whitwell@fda.hhs.gov.
/S/
Isaac K. Carney
Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
CC: Jill Lozmack Mollberg
Feed Field Supervisor
Dairy, Feed and Produce Division
Bureau of Food Safety and Animal Health
Michigan Department of Agriculture and Rural Development
lozmackj@michigan.gov
1
See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)], and 21 CFR 507.1(a)(1)(ii).
2
See Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
3
See Section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)].
4
See Section 402(a)(1) of the FD&C Act [21 U.S.C. § 342(a)(1)].
5
See 21 CFR 507.3.
Content current as of:
05/26/2026
Regulated Product(s)
Animal & Veterinary