Warning Letter — Unilam Co., LTD
The FDA issued a Warning Letter to Unilam Co., LTD. following an assessment by the Center for Devices and Radiological Health (CDRH).
This affects Unilam Co., LTD., as well as regulatory and quality departments involved in the production and oversight of medical devices and radiological health products.
A Warning Letter from CDRH indicates significant regulatory non-compliance that could lead to enforcement actions such as import alerts or the withholding of device approvals. While the source does not specify the exact violations, such letters typically address deficiencies in quality system regulations or pre-market requirements, necessitating immediate corrective actions by the firm to avoid further escalation.
Review internal Quality Management Systems (QMS) for compliance with CDRH standards, ensure all device manufacturing facilities are prepared for potential inspections, and verify that all regulatory filings align with current manufacturing practices.
FDA Warning Letter issued to: Unilam Co., LTD. 09/22/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unilam-co-ltd-738562-09222026
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