1Other quality system
Failure to maintain and review all raw data.
Inspection Record
Sekisui Medical — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Failure to establish a system to control the issuance of documents.
3Cleaning validation
Failure to ensure cleaning procedures are effective.
4Other quality system
Failure to ensure the APIs meet established specifications for quality and purity.
5Other quality system
Failure to prevent unauthorized access of changes to data and to provide adequate controls to prevent omissions of data.
6Process validation
Process validation has not demonstrated the process is in a state of control.
7Other quality system
Failure to establish impurity profiles.
8Other quality system
Failure to design and monitor the water system to ensure it is suitable for its intended use.
9Laboratory and QC controls
Failure to establish scientifically sound and appropriate test procedures.
10Equipment and facility
Equipment is not maintained and cleaned.
About this record
Extracted automatically from the document US FDA published on 2017-05-16. 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.
