1Laboratory and QC controls
Each batch of drug product req uired to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Inspection Record
Takeda Pharmaceutical Company, Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and/or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
4Deviation, CAPA, and investigation
Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to m eet specifications.
About this record
Extracted automatically from the document US FDA published on 2024-11-15. 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.
