1Quality unit oversight
The responsibilities and procedures applicable to the quaJity unit are not in writing and fully followed.
Inspection Record
Catalent Indiana LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Equipment and facility
Equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization processes.
6Process validation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product.
7Documentation and records
Master production and control records lack complete manufacturing and control instructions.
8Material and supplier control
The number of containers and amount of material taken from each container is not based upon appropriate criteria.
About this record
Extracted automatically from the document US FDA published on 2026-07-08. 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.
