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.
See all South Korea findingsWhich agency cited it
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 2026-09-04, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
