1Equipment and facility
Established procedures for DP equipment clean ing and facility surface cleaning are not adequately documented at the time of performance.
Inspection Record
Wuxi Biologics Co., Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The cleaning and disinfecting of the aseptic processing areas are deficient to ensure aseptic conditions are produced.
3Other quality system
The visual inspection program for 6 4 DP vials is deficient.
4Process validation
The in-process parameter setup is inadequate to ensure product quality and process consistency.
5Quality unit oversight
The Quality Unit oversight is deficient.
About this record
Extracted automatically from the document US FDA published on 2025-03-06. 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.
