WARNING LETTER
Hearthy Foods, Inc.
MARCS-CMS 712415 —
February 10, 2026
Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Owner
Hearthy Foods, Inc.
Riaz A. Surti
2043 Imperial St
Los Angeles
,
CA
90021
United States
riaz@hearthyfoods.com
Issuing Office:
Human Foods Program
United States
February 10, 2026
CMS #712415
Dear Mr. Surti:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 2043 Imperial St., Los Angeles, CA 90021, from March 19, 2025, through April 14, 2025. Based on inspectional findings and review of the product labels collected during the inspection, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
At the conclusion of the inspection on April 14, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your responses dated April 24, 2025, and August 11, 2025, and we address your responses below.
Adulterated Conventional Foods
During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA’s inspectional findings, we determined your ready-to-eat (“RTE”) Whey Protein Isolate processed in your facility is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)], in that it was prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth or may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. 331(uu)].
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for your RTE Whey Protein Isolate to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a)(1). Specifically:
a. You did not identify and evaluate recontamination with environmental pathogens (e.g., Salmonella and Listeria monocytogenes) as a known or reasonably foreseeable hazard to determine whether it requires a preventive control, to comply with 21 CFR 117.130(c)(1)(ii). Your facility processes RTE Whey Protein Isolate, which is exposed to the environment and handled by employees at the
(b)(4)
step. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (e.g., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)).
You provided our investigator a sanitation procedure titled “
(b)(4)
”, which includes a description of equipment (e.g., tables, machines, dishes, etc.), frequency of cleaning, and method (e.g., “
(b)(4)
” for machines). It is unclear if your sanitation procedure includes equipment (e.g. hopper on powder-dispensing equipment, storage bins) and the processing room where the RTE Whey Protein Isolate is exposed and at risk of contamination with pathogens. You also provided our investigator with a document titled “
(b)(4)
”, which contains a list of GMP-related instructions, such as “Sanitizer (with rag inside) shall be present at all stations before production is to begin.” However, you are not following your “
(b)(4)
” written procedure. On March 24, 2025, there was no sanitizer available for your production employees to use to sanitize food contact surfaces (e.g., utensils and equipment).
We note that you did not have adequate controls in place for contamination with environmental pathogens, as evidenced by the following observations during
(b)(4)
of RTE Whey Protein Isolate on March 24, 2025:
i. A production employee was observed using their gloved hand to touch a non-food contact surface (i.e., bottom of plastic storage bin, which was rested on a visibly soiled ladder as the production employee ascended and descended the ladder). The employee then touched food (i.e., RTE Whey Protein Isolate) and food contact surfaces (i.e., inside surface of plastic storage bin containing RTE Whey Protein Isolate, and top surface of a production table) using the same gloved hand without first washing or sanitizing their hands or changing their gloves.
ii. A production employee was observed using their gloved hand to touch non-food contact surfaces (e.g., trash bin, wet cloth). The employee then used the same gloved hand to move excess RTE Whey Protein Isolate from the cover of the powder-dispensing equipment (food contact surface) without first washing or sanitizing their hands or changing their gloves. In addition, apparent caked-on food residue or debris was observed on this same cover of the powder-dispensing equipment. The excess RTE Whey Protein Isolate collected from the cover of the powder-dispensing equipment was subsequently used in production.
In addition, when contamination with environmental pathogens is a hazard requiring a preventive control, we note that you must verify the effectiveness of your preventive control by performing environmental monitoring for an environmental pathogen or for an appropriate indicator organism, by collecting and testing environmental samples (see 21 CFR 117.165(a)(3)). You are not performing environmental monitoring to evaluate the effectiveness of your sanitation practices regarding employee practices and cleanliness of food-contact surfaces. Note that when environmental monitoring is required, an environmental monitoring written procedure must be established and implemented and must meet the requirements in 21 CFR 117.165(b)(3).
Furthermore, preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR 117.140).
b. You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Your facility processes various products that contain major food allergens (such as milk and tree nuts). A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR 117.135(c)(2)(ii)).
Regarding the hazard of undeclared allergens, we note that you did not identify milk as a hazard requiring a preventive control. Further, our investigator observed that you did not specifically identify the milk allergen on the product label for your RTE Whey Protein Isolate. On March 26, 2025, you informed our investigator you would recondition
(b)(4)
units of packaged RTE Whey Protein Isolate product (lot “USE BY 03/2027”) on-hand at your facility by placing a sticker on each product label stating, “Contains Milk.” You showed our investigator an example of a reconditioned packaged RTE Whey Protein Isolate for the lot identified as “USE BY 03/2027.” On April 14, 2025, you informed our investigator you
(b)(4)
. However, we are unable to fully evaluate the corrective actions taken in connection with this observation due to a lack of supporting documentation, such as the email sent to your customers.
c. You did not identify and evaluate bacterial pathogens (such as Salmonella) as a known or reasonably foreseeable hazard to determine whether they require a preventive control in your RTE Whey Protein Isolate. Vegetative bacterial pathogens such as Salmonella have been associated with whey protein. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial pathogens as a hazard requiring a preventive control (e.g., a process control or a supply-chain control).
We note that you rely on your supplier to control the hazard of bacterial pathogens. A facility that processes food in your circumstances, which does not receive a lethal treatment at the facility, but which requires a supply-chain control, must establish and implement a risk-based supply-chain program for the ingredients for which the receiving facility has identified a hazard requiring a supply-chain-applied control (see 21 CFR 117.405(a)(1)). The supply-chain program must include, among other requirements, using approved suppliers and conducting appropriate supplier verification activities (see 21 CFR 117.410). Alternatively, a validated lethal treatment must be established and implemented at the facility.
Your written responses indicated you “
(b)(4)
” on April 14, 2025; your onsite manager completed the “
(b)(4)
. However, we are unable to fully evaluate these responses due to a lack of supporting documentation, such as a written hazard analysis.
Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B):
1. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required per 21 CFR 117.35(a). Specifically:
a. On March 19, 2025, debris/apparent food residue was observed on the wall directly behind the powder-dispensing equipment in the production room.
b. On March 19, 2025, a pedestal fan located in the production room was observed to have buildup of filth/debris on the metal wire fan guard.
c. On March 19, 2025, the floor underneath cooking equipment in the production room was observed to have an accumulation of filth/debris.
d. On March 19, 2025, apparent food residue was observed on the bottom shelf of a production table in the production room.
e. On March 24, 2025, the floor drain adjacent to the 3-comparment sink in the production room was observed to contain an accumulation of debris and a section of the floor drain cover was missing.
2. You did not clean your non-food-contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces and food packaging materials, as required per 21 CFR 117.35(e). Specifically, on March 24, 2025, filth/debris was observed on the stepladder used by production employees to reach the hopper of the powder-dispensing equipment during processing of RTE Whey Protein Isolate.
3. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b). Specifically:
a. On March 24 and March 25, 2025, your employees were observed storing personal belongings, including cell phones and cups, in production areas where food is exposed or where equipment or utensils are washed.
b. On March 25, 2025, a production employee was observed heating their personal food in a microwave located near the 3-compartment sink in the production room.
Your written responses indicated you conducted recleaning/repair of the facility, including the production room and non-food-contact surfaces; trained your production employees; obtained a contract with a
(b)(4)
chemical provider; and developed “
(b)(4)
.” However, we are unable to fully evaluate your responses due to a lack of supporting documentation, such as a copy of your Sanitation Standard Operating Procedures. We will verify the adequacy of your corrective actions during a future inspection.
Adulterated Dietary Supplements
The inspection of your facility from March 19, 2025, through April 14, 2025, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Your significant violations of the CGMP requirements are as follows:
1. You failed to, for each dietary supplement that you manufacture, establish product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for limits on those types of contaminants that may adulterate, or that may lead to the adulteration of, the finished batch of the dietary supplement, to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you did not establish product specifications for your Collagen and Collagen+ With Hyaluronic Acid + Vitamin C + Biotin dietary supplement products that you manufacture.
You stated in your August 11, 2025, response that you completed the corrective actions for product specifications on July 1, 2025, namely, establishing “
(b)(4)
.” However, we are unable to evaluate the adequacy of your response because you did not provide supporting documentation, such as copies of the product specifications for your Collagen and Collagen+ With Hyaluronic Acid + Vitamin C + Biotin dietary supplement products.
In addition to establishing the required specifications, you must determine whether such specifications are met, in accordance with 21 CFR 111.73 and 21 CFR 111.75.
2. For each component you use in the manufacture of a dietary supplement, you failed to establish the following component specifications: identity specifications, as required by 21 CFR 111.70(b)(1); component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2); and limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3). Specifically, you did not establish component specifications for the components used to manufacture your Collagen and Collagen+ With Hyaluronic Acid + Vitamin C + Biotin dietary supplement products.
You stated in your August 11, 2025, response that you completed the corrective actions for component specifications on July 1, 2025, namely, establishing “
(b)(4)
.” However, we are unable to evaluate the adequacy of your response because you did not provide supporting documentation, such as copies of the component specifications for your Collagen and Collagen+ With Hyaluronic Acid + Vitamin C + Biotin dietary supplement products.
In addition to establishing the required specifications, you must determine whether such specifications are met, in accordance with 21 CFR 111.73 and 21 CFR 111.75.
3. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you were not able to provide written procedures for quality control operations, and you are not performing any quality control operations during the manufacture of your Collagen and Collagen+ With Hyaluronic Acid + Vitamin C + Biotin dietary supplement products.
You indicated in your August 11, 2025, response that corrective actions for establishing and implementing written procedures for quality control would be completed by September 12, 2025. However, we are unable to evaluate the adequacy of your response because you did not provide supporting documentation, such as a draft of the quality control procedures.
4. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of your dietary supplements that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a) and in accordance with 21 CFR 111.210. Specifically, you stated during the inspection that you
(b)(4)
(e.g., Collagen, Collagen+ With Hyaluronic Acid + Vitamin C + Biotin, Creatine Powder, etc.).
Your August 11, 2025, response stated that you completed a written MMR “
(b)(4)
” on July 28, 2025. You also provided an MMR for Creatine Powder. This MMR is inadequate because it does not include all of the items required in 21 CFR 111.210, such as procedures for sampling and a cross-reference to procedures for tests or examinations. We are unable to evaluate the remainder of your response because you did not provide MMRs for any of your other dietary supplement products, such as your Collagen and Collagen+ With Hyaluronic Acid + Vitamin C + Biotin products.
5. You failed to prepare a batch production record (BPR) every time you manufactured a batch of a dietary supplement, as required by 21 CFR 111.255(a) and in accordance with 21 CFR 111.260. Specifically, you stated during the inspection that you
(b)(4)
, and our investigator observed that you did not prepare a BPR for your Collagen or Collagen+ With Hyaluronic Acid + Vitamin C + Biotin products during manufacturing on March 19 and March 24-25, 2025, respectively.
Your August 11, 2025, response stated that you
(b)(4)
. You also provided a BPR for Creatine Powder. This BPR is inadequate because it does not include all of the items required in 21 CFR 111.260, such as the identity of equipment and processing lines used in producing the batch. We are unable to evaluate the remainder of your response because you did not provide BPRs for any of your other dietary supplement products, such as your Collagen and Collagen+ With Hyaluronic Acid + Vitamin C + Biotin products.
6. You failed to take effective measures to exclude pests from the physical plant, as required by 21 CFR 111.15(d)(2). Specifically, during our inspection, what appeared to be rodent droppings were observed in your dry ingredient storage warehouse and inside your walk-in cooler where dietary supplement packaging materials are stored.
Your August 11, 2025, response noted several completed corrective actions, such as contracting with a “licensed 3rd party pest control provider . . . with Service Reports and applicable Records, including full Integrated Pest Management Program,” and conducting daily and weekly internal GMP inspections. We acknowledge you have hired a third-party pest control company and are documenting pest activity in your Weekly GMP Inspection document. However, we are unable to fully evaluate your response due to a lack of supporting documentation, such as the “Service Reports” referenced in your response.
Misbranded Conventional Foods
We reviewed your Whey Protein Isolate product label and found significant violations of the labeling regulation for foods, 21 CFR Part 101. These violations cause your Whey Protein Isolate to be misbranded within the meaning of section 403 of the Act [21 U.S.C. 343]. Specifically:
1. Your Whey Protein Isolate product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)], in that the finished product label fails to declare the major food allergen, milk, as required by section 403(w)(1) of the Act. Specifically, your Whey Protein Isolate product is manufactured using whey, a protein derived from milk.
Section 201(qq) of the Act [21 U.S.C. 321(qq)], defines “major food allergens” as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. 343(w)(1)(A)]; or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. 343(w)(1)(B)].
2. Your Whey Protein Isolate product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4(a)(1). Your Whey Protein Isolate product label fails to declare sunflower lecithin, which is one of the two components of the bulk ingredient “IWPI90 rBGH Free Non-GMO”.
3. Your Whey Protein Isolate product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Specifically, the product label bears multiple nutrient content claims for protein, such as “30g of protein”, “30 G protein” and “30 grams of protein/serving.” However, the Nutrition Facts label does not comply with 21 CFR 101.9(c)(7), which requires the declaration of a percent Daily Value (%DV) for protein when a claim is made.
Misbranded Dietary Supplements
We also reviewed your product labels collected during the inspection and have determined the Collagen and Collagen+ With Hyaluronic Acid + Vitamin C + Biotin dietary supplements you manufacture are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the labeling requirements for dietary supplements. Specifically:
1. Your Collagen and Collagen+ With Hyaluronic Acid + Vitamin C + Biotin products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] in that the product labels fail to include a statement of identity as a dietary supplement, as required by 21 CFR 101.3(g).
This letter is not intended to be an all-inclusive statement of violations that may exist 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 firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
We also have the following comments:
You manufacture/pack food products containing different allergen profiles (e.g., Whey Protein Isolate (milk); Almond Flour (almond); Cashew Flour (cashew)). As noted above, at the time of the inspection, you had not identified and evaluated allergens as a known or reasonably foreseeable hazard to determine whether they require a preventive control at your facility, as required by 21 CFR 117.130(a)(1). Food allergen controls also include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (see 21 CFR 117.135(c)(2)(i)). We note that on March 25, 2025, our investigator observed that powder-dispensing equipment was used to pack Whey Protein Isolate (milk) prior to cleaning/sanitation. After your production employees completed the cleaning/sanitation process, our investigator observed apparent powder/residue build-up remaining on food contact surfaces of your powder-dispensing equipment. The next product (Collagen+) processed on this powder-dispensing equipment did not contain milk as an ingredient.
Each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility, and the individual’s assigned duties, as required by 21 CFR 117.4(b)(2). You are required to establish and maintain documentation of this training as provided by 21 CFR 117.4(d).
Your Whey Protein Isolate product label declares the net quantity of contents as “
(b)(4)
”. The declaration shall be expressed both in ounces, with identification by weight and, if applicable (1 pound or 1 pint or more) followed in parentheses by a declaration in pounds for weight units, with any remainder in terms of ounces or common or decimal fractions of the pound, as required by 21 CFR 101.7(j)(1).
The actual number of servings on your Whey Protein Isolate product label is not listed before the servings per container declaration as required by 21 CFR 101.9(d)(3)(i).
The % Daily Value footnote of your Whey Protein Isolate product label is not preceded by an asterisk, as required by 21 CFR 101.9(d)(9).
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address 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 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Jamie M. Bumpas, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #712415 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.
Sincerely,
/S/
Thomas Kuntz
Acting Deputy Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
05/05/2026
Regulated Product(s)
Dietary Supplements