Warning Letter Record: Best Buy Bones, Inc. (2026-04-30) — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
TL;DR
The short version: FDA issued a Warning Letter to Best Buy Bones, Inc. on 2026-04-30 citing: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/best-buy-bones-inc-719212-04302026
Argus analysis
Best Buy Bones, Inc. (MARCS-CMS 719212) received an FDA Warning Letter dated April 30, 2026 from the Office of Surveillance and Compliance. The letter cites: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 26, 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
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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 Best Buy Bones, Inc. MARCS-CMS 719212 — April 30, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL NO HARD COPY TO FOLLOW Product: Animal & Veterinary Recipient: Recipient Name Arnold McIntyre/Delbert J. McCord Recipient Title Part Owners Best Buy Bones, Inc. 7426 N Dort Hwy Mount Morris , MI 48458-2232 United States arnoldmcintyre@bestbuybones.com Issuing Office: Office of Surveillance and Compliance United States Secondary Issuing Offices United States April 30, 2026 WARNING LETTER Dear Messrs McIntyre and McCord, The U.S. Food and Drug Administration (FDA) conducted an inspection of your pet food manufacturing facility, located at 7426 N Dort Hwy, Mount Morris, Michigan, from September 8 through September 12, 2025. We have received and evaluated your written responses, dated October 3, 2025, and February 4, 2026, to the Form FDA 483, Inspectional Observations (FDA 483), issued at the close of inspection. During the inspection, an FDA investigator found evidence of significant violations of FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507). These violations cause your products to be adulterated under the Federal Food, Drug, and Cosmetic Act (the Act), 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. 1 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act. 2 Also, 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 (located in subparts A, C, D, E, and F of Part 507) is a prohibited act. 3 During the inspection, on September 9, 2025, an FDA investigator collected samples of your Nature's Own Pet Chews Bully Bites, lot 9/2027. Sample analysis revealed that the sampled lot contained Salmonella Uganda . Therefore, your Nature's Own Pet Chews Bully Bites, lot 9/2027, are adulterated under the Act in that they bear or contain a poisonous or deleterious substance which may render them injurious to health. 4 Your firm initiated a voluntary recall of certain lots of Nature’s Own Pet Chews Bully Bites on October 1, 2025. You may find the Act and FDA’s regulations through links in FDA’s homepage at www.fda.gov. At the close of the inspection, you were issued a form FDA 483, Inspectional Observations. As noted above, we received your written responses, dated October 3, 2025, and February 4, 2026. We have reviewed your responses, and we discuss your corrective actions below in relation to each of the noted violations. Hazard Analysis and Risk-Based Preventive Controls Requirements During our inspection of your facility, the FDA investigator observed evi…
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 FDA violations was Best Buy Bones, Inc. cited for?
- The FDA Warning Letter to Best Buy Bones, Inc. (issuing office: Office of Surveillance and Compliance) cites: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Best Buy Bones, Inc.?
- FDA issued the letter (MARCS-CMS 719212) on 2026-04-30 and posted it publicly on fda.gov on 2026-05-26.
- Is the FDA warning letter to Best Buy Bones, 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/best-buy-bones-inc-719212-04302026.
- What does a "high" severity rating mean for this letter?
- High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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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). Warning Letter Record: Best Buy Bones, Inc. (2026-04-30) — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-best-buy-bones-inc-2026-04-30-cgmp
"Warning Letter Record: Best Buy Bones, Inc. (2026-04-30) — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-best-buy-bones-inc-2026-04-30-cgmp.
Argus HQ Research. "Warning Letter Record: Best Buy Bones, Inc. (2026-04-30) — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-best-buy-bones-inc-2026-04-30-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_best_buy_bones_inc_2026_04_30_cgmp_2026,
title = {Warning Letter Record: Best Buy Bones, Inc. (2026-04-30) — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-best-buy-bones-inc-2026-04-30-cgmp},
note = {Accessed: July 13, 2026}
}