1Equipment and facility
The facility design was observed to allow the influx of poor quality air into a higher classified area.
Inspection Record
Infuscience, Inc. dba Bioscrip Infusion Services — FDA 483 Findings
Inspectors Sena G DissmeyerThe 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
The ISO 5 classified aseptic processing areas had visibly dirty equipment or surface.
3Contamination control
Personnel did not disinfect and change gloves frequently enough to prevent contamination.
4Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.
5Other 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.
6Contamination control
You produced beta.-lactam drugs without providing adequate segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
7Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
About this record
Extracted automatically from the document US FDA published on 2019-10-21. 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.
