Lewis Sausage Company Inc.

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WARNING LETTER
CMS # 717432

August 5, 2026

Dear Donald Myers:

The U.S. Food and Drug Administration (FDA) and North Carolina Department of Agriculture and Consumer Services (NCDACS) conducted a joint inspection of your pet food manufacturing facility, located at 1050 Old Savannah Road, Burgaw, North Carolina, from August 25 through August 29, 2025, as a follow-up to an Untitled Letter issued to your facility on March 14, 2025. We also received and evaluated your written responses to the Form FDA 483, Inspectional Observations (FDA 483), dated September 22, 2025, and March 19, 2026.

During the inspection, the investigators 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), which cause your products to be adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have been 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 control requirements of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is a prohibited act.³

On August 11, 2025, NCDACS, in cooperation with FDA, conducted sampling of (b)(4) Chicken Dog Food, lot (b)(4), (b)(4) Pet Food Mixer, lot (b)(4), and (b)(4) Turkey & Beef Puppy Food, lot (b)(4), which you contract manufacture. The unopened samples were collected from a third-party wholesale distributor. Sample analysis revealed the finished products contained Salmonella or Listeria monocytogenes, as described below. Therefore, your (b)(4) Chicken Dog Food, lot (b)(4), (b)(4) Chicken Pet Food Mixer, lot (b)(4), and (b)(4) Turkey & Beef Puppy Food, lot (b)(4), are adulterated in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.⁴ These pathogen-positive samples led to (b)(4).

This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our inspection of your operation. 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 an FDA 483. As noted above, we received your response dated September 22, 2025, and March 19, 2026. We have reviewed your response, and we discuss your proposed corrections below in relation to each of the noted violations.

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 our inspection of your facility, the investigators observed evidence of significant violations of these requirements, including the following:

1. 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).

Your hazard analysis, titled “(b)(4),” dated July 28, 2025, identified biological hazards including Salmonella, L. monocytogenes, and Escherichia coli O157:H7 as hazards requiring a preventive control at the “(b)(4)” manufacturing step. Your food safety plan identified one process preventive control which includes applying (b)(4) to control pathogen hazards. However, your (b)(4) preventive controls are not adequate, as shown by the following samples⁵ of three finished products that were collected after implementation of your preventive control and found to contain Salmonella or L. monocytogenes:

• Sample (b)(4) Chicken Pet Food Mixer, lot (b)(4), was found to contain Salmonella Enteritidis.
• Sample (b)(4) Chicken Dog Food, lot (b)(4), was found to contain Salmonella Enteritidis.
• Sample (b)(4) Turkey & Beef Puppy Food, lot (b)(4), was found to contain L. monocytogenes.

Additionally, your “(b)(4)” SOP (SOP-507.34-01) states to (b)(4).” You verbally stated during the inspection, the mixing time was (b)(4), which is not established in your written procedure. However, our investigators observed mixing times of 153, 142, and 75 seconds on August 27, 2025, during the production of turkey food for cats, lot (b)(4).

Evaluation of your response:
Your response dated September 22, 2025, included a corrective and preventive action report for the lots of pet food referenced above, an updated hazard analysis that includes an updated preventive control for pathogens, a new monitoring record for the updated preventive control, an updated (b)(4) Procedure, and an assessment of mixing times on (b)(4) distribution. However, your March 19, 2026, response indicates you have replaced (b)(4) in-process ingredients with (b)(4) of finished products in final packaging as a preventive control for biological hazards.

In your March 19, 2026, response, you also presented an updated food safety plan, “Finished Product Pathogen Testing Program” (SOP-507.49.01), and (b)(4) studies (b)(4) of your finished products. Your updated hazard analysis identifies that (b)(4) addresses biological hazards associated with your ingredients and process, and that you have contracted a third-party manufacturing facility to conduct the (b)(4) processing on finished products. However, we are unable to fully evaluate the adequacy of your corrective actions because you did not provide documentation supporting that this preventive control has been implemented for the finished products you manufacture.

2. You did not validate that the preventive controls you identified and implemented in accordance with 21 CFR 507.34 are adequate to control the hazard as appropriate to the nature of the preventive control and its role in your facility’s food safety system, as required by 21 CFR 507.47(a).

Specifically, your firm added (b)(4) as a preventive control for pathogens in your pet food products in accordance with the “(b)(4)” SOP (SOP-507.34-01). You implemented this procedure based upon (b)(4) studies conducted by your third-party consulting laboratory regarding the use of (b)(4) in your pet food products. FDA’s review of your validation studies using (b)(4) to control Salmonella and L. monocytogenes determined these studies do not support your claim that the probiotic is an effective preventive control. This is further demonstrated by the detection of Salmonella or L. monocytogenes in your finished pet food as described above.

Additionally, your validation studies did not address other pathogens you have determined to be hazards requiring a preventive control, such as E. coli O157:H7.

Evaluation of your response:
In your written response, dated September 22, 2025, you provided (b)(4) studies previously submitted to the FDA as well as supplemental information pertaining to the studies. However, your March 19, 2026, response indicated you have replaced the (b)(4) of in-process ingredients with (b)(4) of finished products in final packaging as a preventive control.

Additionally, in your written response, dated March 19, 2026, you presented (b)(4) validation studies for (b)(4). You evaluated the inactivation of Salmonella, L. monocytogenes, and Shiga toxin-producing Escherichia coli using continuous (b)(4) of pathogens. We have reviewed your validations and note the validation studies do not include determination of the pathogenic load for your product before undergoing (b)(4). Without knowing the typical starting pathogenic load for your product, we are unable to determine if the (b)(4) achieved by your (b)(4) validation studies is adequate to significantly minimize⁶ pathogens. We acknowledge that in Table (b)(4) of each study, you analyzed (b)(4) and (b)(4). However, (b)(4) is an indicator of the overall microbial population and does not directly measure the presence/absence of pathogenic microorganisms.

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 regulatory action, or where appropriate, legal action.

For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, 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 FD&C 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 response 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 Andrew J. Howard at Andrew.Howard@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Andrew J. Howard by telephone at (410) 779-5125, or by email.

/S/

Isaac K. Carney
Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration

Cc:
(b)(4)

(b)(6), (b)(7)(C)
North Carolina Department of Agriculture and Consumer Services
4400 Reedy Creek Road
Raleigh, NC 27607
(b)(6), (b)(7)(C)

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1 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).

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 Although NCDACS collected these samples, FDA reviewed and concurred with the NCDACS sample collection and analytical report packages.

6 Significantly minimize means to reduce to an acceptable level, including to eliminate (21 CFR 507.3).