Dough-To-Go, Inc.

The United States Food and Drug Administration (FDA) inspected your manufacturing facility for baked goods and unbaked doughs, located at 3535 De La Cruz Blvd, Santa Clara, CA 95054-2112 from October 29 through November 7, 2025. During our inspection of your facility, an 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 have determined that your Linzer Heart cookies are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], 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. 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)]. You may find the Act and FDA's regulations through links on FDA's website at www.fda.gov.

At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. To date, we have not received your response to the issued FDA-483. Based on our review of the inspectional findings, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility.

1. You did not implement your preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act, as required by 21 CFR 117.135(a)(1).

a. You did not implement your sanitation preventive control for the environmental pathogens hazard. Your hazard analysis for your baked goods appropriately identifies recontamination with environmental pathogens as a hazard requiring a preventive control at post-bake steps such as (b)(4). At these steps, the baked goods are exposed to the environment.

However, you did not follow your facility’s sanitation preventive controls to control the hazard of recontamination with environmental pathogens, as follows:

1) Your GMP Employee Policy1 (Doc #(b)(4), Section IV.E.8) states: “(b)(4).” However, on October 29, 2025, the FDA investigator observed a packaging employee using a frayed, ripped towel to wipe the surface of a scratched wooden packaging table and then wiping their gloved hands on the same towel. Without removing or changing their gloves, the employee immediately proceeded to hand-package RTE products.

2) Your GMP Employee Policy (Doc #(b)(4)) states (b)(4). However, the FDA investigator did not observe any employees apply sanitizer after donning their gloves and before touching RTE products. During the inspection, you stated that within 30 days, employees would be re-trained on sanitizer use. We will evaluate the adequacy of your corrective action during our next inspection.

b. You did not implement your allergen preventive control for the allergen cross-contact hazard.

Your hazard analysis for your baked goods appropriately identifies allergen cross-contact as a hazard requiring a preventive control at steps such as (b)(4). Your firm handles allergens including wheat, eggs, milk, soy, peanuts, and tree nuts (such as macadamia nuts, almonds, and pecans) on food-contact surfaces of shared processing equipment.

However, you did not follow your procedures to control the hazard of allergen cross-contact. Your Allergen Management SOP2 (Doc #(b)(4)) states (b)(4). However, on October 29, 2025, the FDA investigator observed spilled nuts on the floor of the freezer, beside cases holding macadamia nuts and almonds. During the inspection, your firm began to clean the spilled nuts, but the FDA investigator noted there were still some nuts on the floor as of November 7, 2025. You stated (b)(4). We will evaluate the adequacy of your corrective actions during our next inspection.

1. You did not keep the grounds about your plant in a condition that would protect against the contamination of food, as required by 21 CFR 117.20(a).

On November 3, 2025, the FDA investigator observed overgrown weeds, other vegetation, and unused equipment stored directly outside the building (near the employee entrance and outdoor break area). Overgrown vegetation and equipment that is not properly stored could constitute an attractant, breeding place, or harborage for pests. A review of Pest Control Reports dated October 22, 2025, documented heavy mice activity in exterior trap X4, which is located near the employee entrance and was hidden in the overgrown vegetation. During the inspection, you stated (b)(4). We will evaluate the adequacy of your corrective actions during our next inspection.

2. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 117.35(c).

On October 29, 2025, the FDA investigator observed at least three apparent gnats on a cookie decorating table and one apparent rodent excreta pellet on the lower shelf of the dry storage rack. The FDA investigator also observed an approximate (b)(4) gap in the top of the warehouse dock door, creating a potential pest entry point. During the inspection, you removed the apparent rodent excreta pellet and cleaned the lower shelf of the dry storage rack. You also stated (b)(4). We will evaluate the adequacy of your corrective actions during our next inspection.

3. Your equipment and utensils were not adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1).

On 10/29/2025, the FDA investigator observed that the raw dough conveyor belt had two areas of fraying edges, measuring approximately (b)(4) long. Fraying edges of conveyor belts could become harborage points for contaminants and could shed into products such as the Linzer Heart cookies.

This is a repeat observation from the previous FDA inspections conducted on March 18, 2021, and May 22, 2018, where the same conveyor belt was cited as worn and frayed. During the 2021 inspection, your President stated that a new replacement conveyor belt had arrived but had not been installed due to the arduous and expensive task of installing the belt. During the most recent inspection, you stated (b)(4). We will evaluate the adequacy of your corrective action during our next inspection.

4. You did not clean and sanitize your utensils or equipment in a manner that protects against contamination of food, food-contact surfaces, or food packaging materials, as required by 21 CFR 117.35(a).

According to your Sanitizer Solution Log Sheet, your (b)(4). On October 29, 2025, the FDA investigator observed employees performing sanitation on utensils in a three-compartment sink (water rinse, soap and scrubbing, and sanitizer dip). The FDA investigator asked your President to test the quat concentration in the sink-dip (third compartment) using test strips. However, the test strip showed 0 ppm quat in the sink-dip (no color change). During the inspection, you stated (b)(4). We will evaluate the adequacy of your corrective action during our next inspection.

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 your firm complies with all requirements of federal law, including applicable 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, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Please send your written response electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Kathryn Cutajar, Compliance Officer, at Kathryn.Cutajar@fda.hhs.gov. If you have any questions regarding this letter, you may contact Kathryn Cutajar, Compliance Officer, at Kathryn.Cutajar@fda.hhs.gov. Please reference CMS #727845 on any submissions and within the subject line of any emails to us.