2026-05-12 FDA Warning Letter: Dough-To-Go, Inc. Cited for CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
TL;DR
The short version: FDA issued a Warning Letter to Dough-To-Go, Inc. on 2026-05-12 citing: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dough-go-inc-727845-05122026
Argus analysis
Dough-To-Go, Inc. (MARCS-CMS 727845) received an FDA Warning Letter dated May 12, 2026 from the Human Foods Program. The letter cites: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on June 2, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Dough-To-Go, Inc. MARCS-CMS 727845 — May 12, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Ms. Sandra M. Hamel-Dailey Recipient Title Owner and Chief Executive Officer Dough-To-Go, Inc. 3535 De La Cruz Blvd Santa Clara , CA 95054-2112 United States sandra@dough-to-go.com Issuing Office: Human Foods Program United States May 12, 2026 WARNING LETTER Re: CMS # 727845 Dear Ms. Hamel-Dailey: 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. Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C) 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 faci…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Dough-To-Go, Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Dough-To-Go, Inc. as of 2026-06-02. Argus ingests new FDA enforcement records daily.
argus.hq
Don’t find out about the next one six weeks late.
Argus reads every FDA Warning Letter the day it publishes, summarizes it against your watchlist, and lands the ones touching your business in your inbox at 6am ET. $199/month. Cancel any time.
methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-05-12 FDA Warning Letter: Dough-To-Go, Inc. Cited for CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-dough-to-go-inc-2026-05-12-cgmp
"2026-05-12 FDA Warning Letter: Dough-To-Go, Inc. Cited for CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-dough-to-go-inc-2026-05-12-cgmp.
Argus HQ Research. "2026-05-12 FDA Warning Letter: Dough-To-Go, Inc. Cited for CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-dough-to-go-inc-2026-05-12-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_dough_to_go_inc_2026_05_12_cgmp_2026,
title = {2026-05-12 FDA Warning Letter: Dough-To-Go, Inc. Cited for CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-dough-to-go-inc-2026-05-12-cgmp},
note = {Accessed: July 13, 2026}
}