1Other quality system
Corrective actions are not taken when data from critical quality attributes indicate a trend towards out of specification.
Inspection Record
Wuxi Biologics — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit for material suppliers are not fully followed.
3Other quality system
All information to ensure method accuracy, reproducibility, and reliability, is not included in analytical method evaluation to ensure validated QC analytical methods continue to operate in a state of control on a routine basis.
4Aseptic processing and sterility assurance
The amount of samples sufficient to perform all tests, except for endotoxin and sterility, in duplicate, are not retained.
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.
