1Other quality system
SOP's do not provide adequate information to ensure the consistency of assay performance.
Inspection Record
Suzhou Suncadia Biopharmaceutical CO., Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Your firm did not establish appropriate visual inspection (VI) procedures designed to assure batches oq {tiff4lproducts meet the specifications and quality control criteria as a condition for their approval and release.
3Quality unit oversight
The responsibilities and procedures applicable to the quality unit are not in writing and fully followed.
4Laboratory and QC controls
CbTCl Scientifically sound and appropriate controls are not implemented fo manufacturing operation to ensure that drug products conform to appropriate standards of identity, strength, quality and purity.
5Aseptic processing and sterility assurance
Procedures designed to preyent microbiological contamination of drug products purporting to be sterile are not established and fo1lowed.
6Laboratory and QC controls
Appropriate designs to ensure that complete data derived from all tests necessary to assure compliance with established specifications and standards are not included in the laboratory records.
7Other quality system
Capping {tiff-O alidation data to ensure container closure integrity is inadequate.
8Data integrity
Your firm has not established adequate procedural controls over equipment systems to ensure data integrity and system access_ Specifica11y, A) SOP M-00 009 for I CbTpurity analysis by IEC-HPLC describes the assay procedure and chromatogram data integration analysis.
About this record
Extracted automatically from the document US FDA published on 2025-03-28. 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.
