1Aseptic processing and sterility assurance
Aseptic processing areas ai·e deficient regai·ding the system for cleaning an d disinfecting the room an d equipment to produce aseptic conditions.
Inspection Record
Janssen Vaccines Corporation — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Responsibilities and procedures for quality units ai·e not in writing and/or followed to ensure the FARS (BPDR) are submitted for the distributed products that ai·e implicated with product quality issues.
3Aseptic processing and sterility assurance
Procedure designed to prevent microbiological contamination of di11g products pmpo1i ing to be sterile are not established or followed.
4Equipment and facility
Equipment used in the manufacture, processing, packing, or holding of diu g products is not of appropriate design to facilitate operations for its intended use.
5Aseptic processing and sterility assurance
Aseptic processing areas ai·e deficient regai·ding systems for maintaining any equipment used to control the aseptic conditions.
About this record
Extracted automatically from the document US FDA published on 2025-03-06. 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.
