1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written and followed.
Inspection Record
INCELL Corporation LLC — FDA 483 Findings
Inspectors Patrice S HallThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The container labels of your outsourcing facility?s drug products are deficient.
3Environmental monitoring
Specifically, pressure gauges are not installed to monitor the pressure differential or air flow between the ISO 7 Cleanroom, the ISO 8 ante room and the unclassified general environment.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
