FDA Publishes Warning Letter to Ultrasound Gel Manufacturer: Preservative Change Without New 510(k), Contamination Correction Not Reported Within 10 Working Days

News Report

Published: November 5, 2026 | Category: Quality, Clinical, and Cybersecurity

On November 3, 2026, the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), added to its Warning Letters list a letter issued to Next Medical Products Company, LLC. The letter is identified as CMS #727918 and is dated August 19, 2026. It was addressed to the company’s President and Chief Executive Officer at its facility in Branchburg, New Jersey. The letter names four products: Clear Image Ultrasound Gel, Clear Image Sterile, non-sterile MediChoice Ultrasound Gel, and Clear Image Singles.

The inspection took place from November 10 to December 10, 2025, and the FDA Form 483 was issued on December 10, 2025. The company responded on January 2 and March 19, 2026. FDA found the responses inadequate for each listed observation.

Environmental Monitoring: Passing Retest Used to Set Aside Initial Results

The first violation relates to 21 CFR 820.70(c). The company’s procedure “Quality Assurance Environmental Testing,” 907-030, version 005, required environmental testing on packaging lines but did not require investigation of out-of-specification results and did not require written justification for rejecting initial test data. In practice, filling-nozzle samples for a batch of Clear Image ultrasound gel had aerobic colony counts of 4,100 and 4,000 CFU, exceeding the internal limit. After a passing retest, the company released the batch without an out-of-specification investigation and without a written explanation for why the first results could be rejected.

FDA also noted two further points. The worst-case sampling locations specified in the procedure were not supported by data such as bioburden data, and the procedure did not define what constituted a “significant finding.” On September 29, 2025, a monitoring result reached 25,000 CFU or more, but management did not increase testing frequency in response.

CAPA and Design Changes: Unresolved “Whether It Counts” Decisions

The second violation relates to 21 CFR 820.100(a). Although the company’s CAPA procedure stated that employees could propose CAPAs, it did not include all quality data sources in the assessment list. As a result, recurring nonconformities were not converted into CAPAs. From August 27 to October 22, 2025, three batches were packaged in the affected area, and no CAPA was initiated. In another instance, samples were not sent for testing overnight as required by procedure; the issue was recorded only in a note to file, and no CAPA was initiated. The letter also notes that the company had received complaints of abnormal odor and cloudy appearance and confirmed that the product had been contaminated.

The third violation relates to 21 CFR 820.30(i). The company added a new version of a label insert with contraindications and an instruction that sterile gel must be used. The change was prompted by a U.S. CDC-related non-sterile gel contamination event. The company treated the change as a marketing communication and processed only a label approval, without design verification or validation. In a separate case, the company changed the preservative in 2024; the new preservative increased efficacy against Paraburkholderia. The company also did not perform design verification or validation for that change.

Correction Not Reported: The 10-Working-Day Requirement

The letter includes a separate section on 21 CFR 806.10. On July 23, 2025, the company notified customers through a customer letter and phone script, offering free replacement or disposal instructions. CDRH’s clinical review concluded that use of the contaminated gel could pose a health risk. Therefore, the action was a correction or removal initiated to reduce a health risk and was reportable to FDA within 10 working days. No report had been submitted by the end of the inspection on December 10, 2025, and no report had been submitted as of August 13, 2026.

Unapproved Device: What Changed After K883917

The fourth section addresses the 510(k). Clear Image ultrasound scanning gel was originally cleared under K883917 as a coupling agent for ultrasound examinations, used to exclude air between the transducer and the skin for imaging. In 2024, the company changed the preservative in the formulation. FDA considers this a material formulation change that could significantly affect safety or effectiveness and therefore requires a new 510(k) under 21 CFR 807.81(a)(3)(i). The letter requires a new biocompatibility assessment and evidence that the new formulation maintains its preservative efficacy and shelf-life claims throughout the shelf life.

An Easily Overlooked Timing Point: QMSR

At the end of the letter, FDA notes that as of February 2, 2026, 21 CFR Part 820 became the QMSR, aligned with the internationally recognized medical device quality management system standard. The inspection was conducted under the QS regulation in effect at the time, but the company’s corrective actions must be implemented in accordance with the QMSR effective February 2, 2026. The response is due within 15 working days of receipt of the letter.

Source and Applicability

Source: U.S. Food and Drug Administration (FDA), CDRH — Warning Letter CMS #727918, Next Medical Products Company, LLC. Warning Letter signed August 19, 2026; posted on the FDA website November 3, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/next-medical-products-company-llc-727918-08192026

Source: U.S. Food and Drug Administration (FDA) — Warning Letters list page, used to verify the posting date and signing date. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

Verification scope and access date: The full text of the Warning Letter, including the quality system, correction and removal, and unapproved device sections, and the FDA Warning Letters list page were reviewed on November 5, 2026. The clause numbers, sampling values, dates, product names, and inspection start and end dates cited in this article are taken from the Warning Letter.

Applicability: This article is an interpretation of an FDA public enforcement document and does not constitute a conclusion or commitment regarding any specific product, company, or registration application. The findings in the letter apply to the company’s specific facility and specific batches and cannot be directly applied to other products. The relevant requirements are subject to the original FDA text and current regulations, and the information may change with subsequent official updates.

AIMEILI Regulatory Interpretation

This Warning Letter is a useful enforcement signal for ultrasound gel manufacturers and other device companies with established 510(k) clearances. It shows that FDA will treat formulation changes—including preservative changes intended to improve antimicrobial performance—as potentially significant changes requiring a new 510(k) when they may affect safety or effectiveness. A change assessment should therefore be documented before implementation, with biocompatibility, preservative efficacy, and shelf-life validation considered.

The environmental monitoring findings reinforce a core data-integrity principle: a passing retest does not by itself invalidate an initial out-of-specification result. Manufacturers should require a documented investigation, scientifically justified sampling locations, defined escalation triggers, and written rationale for any rejection of initial data. Recurring environmental monitoring excursions, complaints, and contamination signals should be evaluated through the CAPA system, not handled as isolated events.

The design-change section also matters for labels and instructions for use. Changes that add contraindications or use instructions, particularly those intended to address a contamination-related safety concern, should be assessed under design control and may require verification and validation rather than label approval alone.

Finally, the letter illustrates the practical reach of 21 CFR 806.10. Customer notifications offering replacement or disposal instructions can be reportable corrections or removals when initiated to reduce a health risk. Regulatory teams should maintain a documented reportability assessment and submit a correction/removal report within 10 working days when the threshold is met. The QMSR transition adds a further point: although the inspection was under the QS regulation, remediation must be designed to meet QMSR requirements effective February 2, 2026.

Business Impact

For manufacturers of ultrasound gels and other patient-contacting devices, the immediate priority is a gap assessment covering formulation and preservative changes, 510(k) change control, environmental monitoring, CAPA, complaint handling, and correction/removal reporting. Suppliers and distributors should also review whether any affected products or comparable products require additional due diligence, including warning letter checks and audit readiness. CROs supporting regulatory submissions should incorporate these expectations into gap assessments and submission strategies.

Regulatory affairs and quality teams should expect increased scrutiny of:

• whether formulation changes to cleared devices require a new 510(k), supported by biocompatibility and shelf-life data;
• whether environmental monitoring procedures define investigation, data rejection, worst-case sampling, and escalation requirements;
• whether CAPA procedures capture all quality data sources and recurring nonconformities;
• whether label and IFU changes are assessed through design control;
• whether customer notifications and field actions are assessed for 21 CFR 806 reportability within 10 working days;
• whether corrective actions are aligned with QMSR requirements.

These actions can help reduce the risk of warning letters, recall or correction reporting delays, and market access disruption, while supporting inspection readiness for global registration and distribution.