Warning Letter — JMT Inter LLC
The FDA issued a Warning Letter to JMT Inter LLC following an inspection by the Office of Inspections and Investigations. The letter reflects regulatory violations identified during the agency's oversight activities.
This notice affects JMT Inter LLC and its operational departments responsible for quality management, regulatory compliance, and facility inspections.
The issuance of a Warning Letter indicates that the FDA identified significant violations of regulatory requirements that require formal corrective action. Failure to address these concerns could lead to further enforcement actions, such as seizures, injunctions, or restricted ability to market products. While the source excerpt does not detail the specific violations, Warning Letters typically signal a breakdown in quality oversight or non-conformance with safety and labeling standards.
Review the specific observations cited in the linked Warning Letter (718661) to identify potential gaps in internal quality systems. Ensure all manufacturing and distribution records are readily accessible for FDA inspection and that corrective actions address the root causes of regulatory deviations.
FDA Warning Letter issued to: JMT Inter LLC. 02/19/2026 — Office of Inspections and Investigations. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jmt-inter-llc-718661-02192026
Open in openFDA / FDA.gov