1Other quality system
There is a failure to thoroughly review any unexplained discrepancywhether or not the batch has been ah-eady distributed.
Inspection Record
Catalent Belgium SA — FDA 483 Findings
Inspectors Yasamin AmeriThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Control procedures are notestablished which monitor the output and validate the perfo1mance ofthose manufacturing processes that may be responsible for causing variability in the characteristics ofin- process material and the dmg product.
3Other quality system
Procedures to ensure that all purchased or othe1wise received productand services confo1m to specified requirements have not been adequately established.
4Other quality system
Not annotated SEE REVE.RSE OF THIS PAGE
5Computer system validation
Backup data is not assured as exact, complete and secure from alteration, era sure or loss through keeping hard copy or alternate systems.
6Other quality system
Input to and output from the computer are not checked for accuracy.
7Other quality system
Quality audits have not been perfo1m ed.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency paiiiculate air filters under positive pressure.
9Other quality system
The design histo1y file was not established.
About this record
Extracted automatically from the document US FDA published on 2022-10-20. 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.
