2026-05-14 FDA Warning Letter: Bushman Organic Farms, Inc. Cited for Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
The short version: The FDA issued a warning letter to Bushman Organic Farms, Inc. (CEO Todd J. Bushman, Calmar, IA) on May 14, 2026 (CMS #729451) following inspections conducted August 15–September 27, 2023 and March 17–27, 2026, citing violations of the Foreign Supplier Verification Program (FSVP) regulation under 21 CFR part 1, subpart L. The company failed to develop, maintain, and follow an FSVP for imported organic soybean meal from multiple suppliers, contrary to section 805 of the Federal Food, Drug, and Cosmetic Act. The FDA requested a written response within 15 working days addressing corrective actions and warned that failure to comply may result in detention without physical examination or refusal of admission for imported foods.
Argus analysis
# FDA Warning Letter Analysis: Bushman Organic Farms, Inc.
## Company and Findings
Bushman Organic Farms, Inc., a food importer based in Calmar, Iowa, received a Warning Letter from the FDA's Human Foods Program on May 14, 2026, following inspections conducted in August–September 2023 and March 2026. The FDA determined the company failed to establish a Foreign Supplier Verification Program (FSVP) for organic soybean meal imported from multiple suppliers. The company had not responded to FDA observations documented on March 27, 2026, prompting the formal warning.
## Regulatory Citations and Implications
The violations center on 21 CFR Part 1, Subpart L (the FSVP regulation) and Section 805 of the Federal Food, Drug, and Cosmetic Act. These provisions require importers to develop, maintain, and follow written verification programs demonstrating that imported food meets U.S. safety standards. The failure to implement any FSVP for imported products represents a fundamental compliance gap. Under 21 CFR 1.502(a), importers must document risk-based supplier evaluations, records reviews, and food safety controls. The absence of such documentation signals inadequate oversight of foreign supply chains.
## Response Timeline and Industry Monitoring
Bushman Organic Farms has 15 working days to submit a written response addressing the violations and detailing corrective actions. The company should provide copies of newly established FSVP documentation and implementation records. Industry observers should monitor whether the FDA escalates enforcement through detention without physical examination (DWPE) under Import Alert #99-41 or refuses admission of the company's imported products under Section 801(a)(3). Continued non-compliance could result in importation prohibitions under Section 301(zz) of the FD&C Act.
Severity context
Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
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 Bushman Organic Farms, Inc. MARCS-CMS 729451 — May 14, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Todd J. Bushman Recipient Title CEO Bushman Organic Farms, Inc. 1402 Highway 150 Calmar , IA 52132-7608 United States Issuing Office: Human Foods Program United States 05/14/2026 WARNING LETTER Re: CMS # 729451 Dear Mr. Todd J. Bushman On August 15 – September 27, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Bushman Organic Farms, Inc. located at 1402 Highway 150 Calmar, IA 52132-7608. We also conducted an inspection on March 17 – March 27, 2026. These inspections were 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 21 CFR part 1, subpart L. 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 most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on March 27, 2026. Your significant violations of the FSVP regulation are as follows: You did not develop, maintain, and follow 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 foods you import, including each of the following foods: Organic soybean meal imported from (b)(4) , located in (b)(4) Organic soybean meal imported from (b)(4) , located in (b)(4) Organic soybean meal imported from (b)(4) , located in (b)(4) Organic soybean meal imported from (b)(4) located in (b)(4) Organic soybean meal imported from (b)(4) located in (b)(4) Organic soybean meal imported from (b)(4) located in (b)(4) Organic soybean meal imported from (b)(4) located in (b)(4) Organic soybean meal imported from (b)(4) located in (b)(4) Organic soybean meal imported from (b)(4) located in (b)(4) Organic soybean meal imported from (b)(4) located in (b)(4) Organic soybean meal imported from (b)(4) located in (b)(4) The above violations are not intended to be an all-inclusive list of vio…
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
- When did FDA issue the warning letter to Bushman Organic Farms, Inc.?
- FDA issued the letter (MARCS-CMS 729451) on 2026-05-14 and posted it publicly on fda.gov on 2026-07-07.
- Is the FDA warning letter to Bushman Organic Farms, Inc. publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bushman-organic-farms-inc-729451-05142026.
- What does a "low" severity rating mean for this letter?
- Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
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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). 2026-05-14 FDA Warning Letter: Bushman Organic Farms, Inc. Cited for Foreign Supplier Verification Program (FSVP). Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-bushman-organic-farms-inc-2026-05-14-warning-letter
"2026-05-14 FDA Warning Letter: Bushman Organic Farms, Inc. Cited for Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-bushman-organic-farms-inc-2026-05-14-warning-letter.
Argus HQ Research. "2026-05-14 FDA Warning Letter: Bushman Organic Farms, Inc. Cited for Foreign Supplier Verification Program (FSVP)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-bushman-organic-farms-inc-2026-05-14-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_bushman_organic_farms_inc_2026_05_14_warning_letter_2026,
title = {2026-05-14 FDA Warning Letter: Bushman Organic Farms, Inc. Cited for Foreign Supplier Verification Program (FSVP)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-bushman-organic-farms-inc-2026-05-14-warning-letter},
note = {Accessed: July 13, 2026}
}