Inspection Record

Samsung Biologics — FDA 483 Findings

US FDAInspected 2022-06-09Published 2024-07-15 3 findingsDeviation, CAPA, and investigationEquipment and facilityOther quality system

View the regulator's official source The source document is always the basis for judgement.

Findings

1Deviation, CAPA, and investigation

The endotoxin detection method is not reliable to detect endotoxin consistently in all the in-process and release samples for l (b)< 4 ~ During the investigation of endotoxin non-confo1mance 4 results (NCR), the film re-tested the samples with fb) < > IEndotoxin Specific (ES) buffer and the test results suggested1 <6Hj interference.

2Equipment and facility

Written procedures for cleaning and maintenance provide inadequate description of actions to be taken and/or not followed.

3Other quality system

fuvestigations conducted to resolve assay failures were inadequate.

About this record

Extracted automatically from the document US FDA published on 2024-07-15. The source is available at the link above.

This is a record of that moment. 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 it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

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