1Quality unit oversight
The Quality Unit oversight over the issuance of controlled documents is deficient.
Inspection Record
Wuxi Biologics — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Effectiveness Checks for corrective and preventative actions implemented in response to a deviation investigations are not always initiated.
3Material and supplier control
The specifications established for components used in the production of drug substance are deficient in that they do not include a description of the sampling plan.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and 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.
5Computer system validation
Appropriate controls are not exercised over computer systems or related systems to prevent changes to data.
6Equipment and facility
Adequate schedules have not been established for the preventative maintenance of equipment.
About this record
Extracted automatically from the document US FDA published on 2022-03-15. 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.
