WARNING LETTER

Supercan Bully Sticks LLC MARCS-CMS 709766 — September 24, 2025

Delivery Method:: Via Express Delivery
Product:: Food & Beverages

Recipient:: Recipient Name

Mr. Julio Stephan Silva Hallemann; Recipient Title

Owner; Supercan Bully Sticks LLC; 8467 NW 74th St.
Miami, FL 33166-2325
United States

Issuing Office:: Division of Southeast Imports; United States

September 24, 2025

WARNING LETTER

Re: CMS # 709766

Dear Mr. Julio Stephan Silva Hallemann:

On April 17 through April 23, 2025, the U.S. Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Supercan Bully Sticks LLC located at 8467 NW 74th St. Miami, FL 33166. This inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in Title 21, Code of Federal Regulations, Part 1, Subpart L (21 CFR Part, 1 Subpart L). Additionally, on April 21 through May 22, 2025, FDA conducted an inspection covering Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements in 21 CFR Part 507. Based on the inspectional findings, FDA’s investigators found evidence of serious violations of the FD&C Act and applicable regulations which are discussed below.

These inspections were initiated in response to a voluntary Class 1 recall by your firm on March 28, 2025, of Supercan Pig Ear Slivers –Thick Cut Piggy Ear Slices pet treats, expiration date 11/09/2026, due to the presence of Salmonella enterica detected by the Washington State Department of Agriculture. FDA considers this lot of pet food to be adulterated in that in that it bears or contains a poisonous or deleterious substance which may render it injurious to health.¹ The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.²

You may find the FD&C Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.

At the conclusion of each of the inspections, our Investigators provided you with a list of our observations via a Form FDA 483a, FSVP Observations (Form FDA 483a) on April 23, 2025, and a Form FDA 483, Inspectional Observations (FDA 483) on May 22, 2025. We have not received a written response to either the Form FDA 483a or FDA 483 as of the date on this letter.

Foreign Supplier Verification Program (FSVP)

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the April 17 through April 23, 2025 inspection, we found that you are not in compliance with the requirements of 21 CFR Part 1, Subpart L for the animal food products you import. Because of this significant violation, you are not in compliance with section 805 of the FD&C Act. The importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited.³

Your significant violations of the FSVP regulation are as follows:

1. You did not develop, maintain, and implement an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the food products you import, including, but not limited to:

Pig Ears Slivers Pet Chews and (b)(4), imported from (b)(4), located in (b)(4).
Pig Ears Slivers Pet Chews, imported from (b)(4), located in (b)(4).

We acknowledge that during the FSVP inspection, you told our Investigator that you intended to have an FSVP plan within 10 days. As of the date of this letter, we have not received any information regarding your FSVPs or planned corrective actions.

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 April 21 through May 22, 2025 inspection of your facility, the FDA Investigators observed evidence of a significant violation of these requirements which causes your products to be adulterated 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.⁴ In addition, 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 is a prohibited act.⁵

Your violations include 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(a). The preparation of the food safety plan must be overseen by your preventive controls qualified individual (PCQI), as required by 21 CFR 507.31(b), and must include the following, in accordance with 21 CFR 507.31(c):

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); and
g. The written verification procedures as required by 21 CFR 507.49(b).

Specifically, during the inspection you were unable to provide a written food safety plan, including a hazard analysis and other required components. You stated that you have not conducted a hazard analysis and do not have a written food safety plan.

Conclusion

This letter is not intended to be an all-inclusive list of violations that may exist at your facility or in connect 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 are in compliance with all requirements of the 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. Additionally, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the foods you import for which you appear to be in violation of section 805 of the FD&C Act. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html.

Furthermore, we offer the following comments:

The FSVP regulation generally requires that you conduct a written hazard analysis (21 CFR 1.504), evaluate foreign supplier performance (21 CFR 1.505), conduct foreign supplier verification activities (21 CFR 1.506), and promptly take appropriate corrective actions (21 CFR 1.508). Specifically, for the FSVPs you are required to develop:

o You must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, and the implementing regulations, or produces food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the FD&C Act. This determination could be based on a review of consumer, customer, or other complaints related to food safety, the verification activities conducted under 21 CFR 1.506, a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under 21 CFR 1.505(c) or (d), or any other relevant information you obtain. The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. You must document any corrective actions you take in accordance with 21 CFR 1.508(a). We note that pet chew products you imported from (b)(4) were detained in (b)(4) due to the presence of Salmonella Javiana and these products were added to Import Alert 71-04 on (b)(4). After becoming aware of such findings, we expect importers to promptly implement and document appropriate corrective actions, which will be verified during future inspections.

o You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection, as required by 21 CFR 1.509(a). Your most recent shipments of pet foods (submitted on (b)(4), and (b)(4)) were transmitted with the FSVP Importer email address of (b)(6). During the FSVP inspection prior to these shipments, you stated that this email address was incorrect and that you would ensure future entries would be submitted with the correct email address, as required under 21 CFR 1.509(a). We note that this discussion item has not been observed to be corrected.

During the inspection, it was noted that some of your pet treat products contain color additives. You provided documentation for multiple color additives, including (b)(4), also known as (b)(4). The FD&C Act provides that any substance that is capable of imparting color when added or applied to a food is a color additive. Color additives are subject to FDA premarket approval before they may be used in food unless the substance is used in a product solely for a purpose other than coloring and is clearly unimportant to the marketability of the product.⁶ When a petition for a color additive is approved, FDA issues an order in the form of a regulation outlining the conditions of use of the color. In general, a color additive is deemed unsafe within the meaning of section 721(a) of the FD&C Act unless its use conforms with a regulation listing the color additive and describing the conditions for its safe use. There is no regulation listing (b)(4) as safe for use in any food. The use of an unsafe color additive in a food causes the food to be adulterated.⁷ We also note that when conducting your hazard analysis, 21 CFR 507.33(b)(1)(ii) requires you to consider any known or reasonably foreseeable hazards that include chemical hazards, such as unapproved color additives. You can find more information about color additives in food at https://www.fda.gov/food/color-additives-information-consumers/color-additives-foods.
FDA has determined that your facility is subject to the food facility registration requirement in section 415 of the FD&C Act [21 U.S.C. § 350d] and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act.⁸ (b)(3)(A)

FDA currently recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI. Dun and Bradstreet assigns and manages DUNS numbers, which are available free of charge. Information on obtaining a DUNS number is available at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006832.htm. You may complete your food facility registration online at www.access.fda.gov. Registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. For animal food facilities specifically, additional information and guidance on qualified facility attestations can be found at https://www.fda.gov/animal-veterinary/animal-foods-feeds/animal-food-facility-registration-and-qualified-facility-attestation-frequently-asked-questions.

Food facilities subject to registration requirements must also comply with the Reportable Food Registry (RFR) requirements in section 417 of the FD&C Act. The RFR provides a mechanism to track patterns of adulteration in food, including animal food, to support efforts by FDA to target inspection resources and protect public health. The RFR requires a “responsible party” to file reportable food reports. The responsible party is the person who submits the registration under section 415 of the FD&C Act for a food facility that is required to register and at which the reportable food was manufactured, processed, packed, or held.⁹ The responsible party is required to file a notification within 24 hours of determining that an article of food is a “reportable food.” A reportable food is an article of food for which there is reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. Failure to submit a required reportable food report is a prohibited act under the FD&C Act.¹⁰ Information on the RFR can be found at https://www.fda.gov/food/compliance-enforcement-food/reportable-food-registry-industry.

For more information about FDA’s current thinking on the FSVP requirements of 21 CFR Part 1, Subpart L, see:

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry https://www.fda.gov/media/118241/download
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) Regulation Records Requirements https://www.fda.gov/media/131229/download

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
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 from 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.

The Food & Drug Administration 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 send your reply to Food and Drug Administration, Attention: Coral del Mar Lopez, Compliance Officer, Division of Southeast Imports, 959 Ridgeway Loop Rd. Suite #100, Memphis, TN 38120. If you have any questions regarding this letter, you may contact Officer Lopez via email at coraldelmar.lopez@fda.hhs.gov. Please reference CMS No. 709766 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Isaac K. Carney
/S/

Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
U.S. Department of Health and Human Services

/S/

Christopher Boulmay
Acting Program Division Director, Division of Southeast Imports
Office of Inspections and Investigations
U.S. Food and Drug Administration
U.S. Department of Health and Human Services

___________________

1 See section 402(a)(1) of the FD&C Act [21 U.S.C § 342(a)(1)].

2 See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

3 See section 301(zz) of the FD&C Act [21 U.S.C. § 331(zz)].

4 See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).

5 See section 301(uu) of the FD&C Act [21 U.S.C. § 342(uu)].

6 See Section 721 of the FD&C Act [21 U.S.C. § 379e].

7 See Section 402(c) of the FD&C Act [21 U.S.C. § 342(c)].

8 See section 301(dd) of the Act [21 U.S.C. § 331(dd)].

9 See Sections 415 and 417(a)(1) of the FD&C Act [21 U.S.C. §§ 350d and 350f(a)(1)].

10 See Section 301(mm) of the FD&C Act [21 U.S.C. § 331(mm)].