1Deviation, CAPA, and investigation
Laboratory investigations for OOS intermediate batches are not conducted.
Inspection Record
Dishman Carbogen Amcis Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Specifically, ( intermediate) batch tested OOS for impurity The batch was manufactured starting on 3/05/2018.
3Other quality system
Blending of in-specification with out-of-specification (OOS) intermediate batches is performed.
About this record
Extracted automatically from the document US FDA published on 2018-12-10. 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.
