1Other quality system
In-proc.es.s sampJes are not fel'.JFCS4.mlativ~.
Inspection Record
Catalent Indiana LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Control pro~-es ara not established which moniwr the output and validate the performanc-e ofthose 1INIDufacturing pr~.sscs thJtt muy be responsible fr1r causinl!; varia.bilil)" in 1hr: chalacteristics of in proocS!> materiPl 3ild the drug product.
3Aseptic processing and sterility assurance
Pr,ocedmes designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established.
4Other quality system
'.Equip11-ent used iD die .r:nanuracruring ofa drug product is not ofappropriate de!rign to :mcilimt0 operations for its intended 1.ase.
5Other quality system
Y,our fim1 failed to eistabli:;·h eind follow adt,::tJtt..1atc control p.rocr..-dltl'e.,.
About this record
Extracted automatically from the document US FDA published on 2023-07-21. 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.
