Infusion Partners, LLC — FDA 483 Findings

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.

Your facility design allowed the influx of poor quality air into a higher classified area.

Personnel did not disinfect and change gloves frequently enough to prevent contamination.

Materials or supplies were not disinfected prior to entering the aseptic processing areas.

Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.

The ISO 5 classified aseptic processing areas had visibly dirty equipment or surface.

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.

You produced beta-lactam drugs without providing adequate containment and segregation to prevent cross-contamination.

Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.

Personnel moved rapidly in the vicinity of open sterile units and instruments, which disrupted the airflow and increased the risk of bringing lesser quality air into the ISO 5 classified aseptic processing area.