US FDA
Dexcowin Co. Ltd.
2026-07-27
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
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South Korea manufacturing-site findings
at manufacturing sites in this country 49 findings drawn from 13 published documents. The most recent cases are below; the full set is in search.
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US FDA
49
Companies with the most findings
Recent findings
US FDA
Samsung Bioepis Co. Ltd.
2025-05-23
Responsibilities and procedures for quality units are not in writing and/or followed to ensure a need for Biological Product Deviation Report (BPDR) are adequately assessed and reported for the distributed products that are implicated with product quality issues.
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US FDA
Samsung Bioepis Co. Ltd.
2025-05-23
Procedures describing the handling of written and oral complaints related to dtu g products are not written and/or followed.
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US FDA
Janssen Vaccines Corporation
2025-03-06
Aseptic processing areas ai·e deficient regai·ding the system for cleaning an d disinfecting the room an d equipment to produce aseptic conditions.
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US FDA
Janssen Vaccines Corporation
2025-03-06
Responsibilities and procedures for quality units ai·e not in writing and/or followed to ensure the FARS (BPDR) are submitted for the distributed products that ai·e implicated with product quality issues.
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US FDA
Janssen Vaccines Corporation
2025-03-06
Procedure designed to prevent microbiological contamination of di11g products pmpo1i ing to be sterile are not established or followed.
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These findings are a record of the moment each document was published. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out — do not read them as the current state; check the regulator's official announcements for the latest status. Counts are measured from public data as of 2026-10-20, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
