1Aseptic processing and sterility assurance
Aseptic processing areas ai·e deficient regai·ding the system for monitoring environmental conditions.
Inspection Record
Catalent Indiana LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent Inicrobiological contamination of drng products purpo1ting to be sterile are not established, written and followed.
3Deviation, CAPA, and investigation
Written records of investigations into the failme of a batch or any of its components to meet specific.ations do not always include the conclusions and follow-up.
4Quality unit oversight
The respousibilities and procedures applicable to the quality control unit are not in writing and fully followed.
5Process validation
Control procedures are not established which monitor the output and validate the perfo1mance ofthose manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the drug product.
6Material and supplier control
Repo11s of analysis from component suppliers are accepted in lieu of testing each component for confonnity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
About this record
Extracted automatically from the document US FDA published on 2025-12-15. 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.
