2026-05-20 FDA Warning Letter: 3B Medical, Inc. dba Reach Health, Inc. Cited for CGMP/QSR/Medical Devices/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/QSR/Medical Devices/Adulterated
TL;DR
Key takeaway: FDA's Center for Devices and Radiological Health issued a warning letter (CMS #725108, dated May 20, 2026) to 3B Medical, Inc. dba Reach Health, Inc. (Dublin, OH) for manufacturing iCodeConnect software and importing ventilator devices (Luna G3 APAP/BPAP, etc.) in violation of Quality System Regulation requirements under 21 CFR Part 820. The inspection (December 1-10, 2025) found the devices adulterated due to failure to establish proper complaint-handling procedures, including improper cancellation of complaints that met the regulatory definition and failure to evaluate whether complaints required Medical Device Reporting (MDR) submission to FDA.
Argus analysis
# FDA Warning Letter Analysis: 3B Medical, Inc. dba Reach Health, Inc.
**Company and Findings**
3B Medical, Inc., operating as Reach Health, Inc., received a warning letter from the FDA's Center for Devices and Radiological Health on May 20, 2026, following a December 2025 inspection of its Dublin, Ohio facility. The company manufactures iCodeConnect, a cloud-based software device used with CPAP and APAP ventilators for obstructive sleep apnea treatment, and imports ventilator and oxygen concentrator devices from a Chinese manufacturer. FDA investigators determined these devices are adulterated because manufacturing and quality systems do not comply with current good manufacturing practice requirements.
**Regulatory Citations**
The violations center on 21 CFR Part 820, the Quality System Regulation. Specifically, 21 CFR 820.198(a) requires firms to establish formal complaint-handling procedures that ensure uniform, timely processing and proper evaluation for Medical Device Reporting (MDR) obligations under 21 CFR Parts 803 and 804. The inspection found that 3B Medical cancelled or misclassified numerous complaints—7 of 11 reviewed were improperly closed, and 13 of 15 inquiries should have been logged as complaints. Additionally, procedures failed to capture follow-up information for serious allegations, such as complaints documenting choking and shortness of breath, which may have triggered mandatory MDR filings that were never submitted.
**Next Steps and Industry Watch Points**
The company provided responses on January 2, February 13, and March 27, 2026. Compliance officers in respiratory device manufacturing should monitor whether 3B Medical issues a public corrective action plan, undertakes complaint system retraining, or faces FDA enforcement actions such as product seizures or consent decrees. Industry peers should examine their own complaint classification criteria and MDR decision trees, particularly whether borderline incidents are being filtered out prematurely rather than evaluated through proper medical assessment protocols.
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 3B Medical, Inc. dba Reach Health, Inc. MARCS-CMS 725108 — May 20, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name William H. Shoop Recipient Title CEO 3B Medical, Inc. dba Reach Health, Inc. 5475 Rings Road Dublin , OH 43017 United States (b)(4) Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER CMS # 725108 May 20, 2026 Dear Mr. Shoop: During an inspection of your firm located in Dublin, OH from December 1, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures iCodeConnect, a cloud-based software device, intended for use in conjunction with Continuous Positive Airway Pressure (CPAP) and Auto-Adjusting Positive Airway Pressure (Auto-CPAP or APAP) ventilator devices, in treating obstructive sleep apnea (OSA) in adults. Your firm also imports and provides complaint handling for APAP and Bilevel Positive Airway Pressure (BPAP) ventilator devices from BMC Medical Co., Ltd. (Beijing, China) to include, but not limited to, Luna G3 APAP (LG3600), G3X APAP (G4600), Luna G3 BPAP (LG3700), Luna G3 30VT (LG3800), and Luna G2 APAP (LG2A02). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Quality System Regulation Violations This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Rebecca Legare, Quality Systems and Compliance Director, dated January 2, 2026, and February 13, 2026, and from Shalini Yadav, Senior Manager of Regulatory Affairs on March 27, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following: 1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner and complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of this chapter, Medical Device Reporting (MDR), as r…
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 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 3B Medical, Inc. dba Reach Health, Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for 3B Medical, Inc. dba Reach Health, Inc. as of 2026-06-30. Argus ingests new FDA enforcement records daily.
- What FDA violations was 3B Medical, Inc. dba Reach Health, Inc. cited for?
- The FDA Warning Letter to 3B Medical, Inc. dba Reach Health, Inc. (issuing office: Center for Devices and Radiological Health) cites: CGMP/QSR/Medical Devices/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to 3B Medical, Inc. dba Reach Health, Inc.?
- FDA issued the letter (MARCS-CMS 725108) on 2026-05-20 and posted it publicly on fda.gov on 2026-06-30.
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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). 2026-05-20 FDA Warning Letter: 3B Medical, Inc. dba Reach Health, Inc. Cited for CGMP/QSR/Medical Devices/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-3b-medical-inc-dba-reach-health-inc-2026-05-20-cgmp
"2026-05-20 FDA Warning Letter: 3B Medical, Inc. dba Reach Health, Inc. Cited for CGMP/QSR/Medical Devices/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-3b-medical-inc-dba-reach-health-inc-2026-05-20-cgmp.
Argus HQ Research. "2026-05-20 FDA Warning Letter: 3B Medical, Inc. dba Reach Health, Inc. Cited for CGMP/QSR/Medical Devices/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-3b-medical-inc-dba-reach-health-inc-2026-05-20-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_3b_medical_inc_dba_reach_health_inc_2026_05_20_cgmp_2026,
title = {2026-05-20 FDA Warning Letter: 3B Medical, Inc. dba Reach Health, Inc. Cited for CGMP/QSR/Medical Devices/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-3b-medical-inc-dba-reach-health-inc-2026-05-20-cgmp},
note = {Accessed: July 13, 2026}
}