1Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations 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.
Inspection Record
InfuScience , Inc . dba Bioscrip Infusion Services — FDA 483 Findings
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 particle-generating and visibly dirty equipment or surface.
3Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
4Validation and qualification
IS0-5 classified areas were not certified under dynamic conditions.
About this record
Extracted automatically from the document US FDA published on 2021-11-19. 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.
