Issued to BMC Medical Co., Ltd.. Serious post-market compliance violation.
Issued
May 20, 2026Product
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Company
BMC Medical Co., Ltd.
Review center
CDRHStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to BMC Medical Co., Ltd. concerning CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Unapproved products and premarket authorization, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on May 20, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.