1Computer system validation
Your firm has not established adequate procedural controls to protect the electronic data acquisition and manufacturing control systems used for DS manufacturing in Building!
Inspection Record
AGC Biologics — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Standard Operating procedures or work instructions are not followed or are inadequate.
3Quality unit oversight
Your firm’s quality unit’s oversight of your GMP manufacturing operations is inadequate.
4Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies, the failure of a batch or any of its components to meet specifications, do not always include the appropriate conclusions and follow-up.
About this record
Extracted automatically from the document US FDA published on 2024-01-31. 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.
