1Aseptic processing and sterility assurance
Equipment was not disinfected prior to entering the aseptic processing areas.
Inspection Record
Innoveix Pharmaceuticals Inc — FDA 483 Findings
Inspectors Jason R CaballeroThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
3Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
4Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
5Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had particle-generating and visibly dirty equipment or surface.
6Other quality system
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.
7Aseptic processing and sterility assurance
Un-protected product intended to be sterile was exposed to lower than ISO 5 classified aseptic processing area quality air.
8Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of personnel and materials.
About this record
Extracted automatically from the document US FDA published on 2019-11-05. 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.
