Advanced Nutriceuticals, LLC — FDA 483 Findings

The final containers/closures used for drug product intended to be sterile were not sterilized or <Redacted B4> A) <Redacted B4> vials were not appropriately handled and stored to ensure sterility at time of use, specifically, <Redacted B4> bags are reused for storing sterile vials after the vials are <Redacted B4>.

Your employee produced a sterile drug product using expired material Specifically, On 10/16/2020, your Phlebotomist <Redacted B4> prepare and administer an IV bag containing Taurine, LOT 0827202007 in the ISO 5 IV hood.

Your employees touched equipment and other surface areas outside the ISO 5 area with gloved hands and proceeded to aseptically process drug product without changing or sanitizing gloves.

Your sterile technician stoppered sterile drug vials.

Systems for monitoring processing and environmental conditions in aseptic processing areas were deficient.

Your sterile technician moved rapidly in the vicinity of open sterile units or instruments.

Your sterile technician conducted aseptic manipulation and placed equipment/supplies in an area that blocks the movement of first pass air around an open unit.

Beta-lactam and hazardous drugs were produced without providing adequate containment, segregation, and cleaning of work surfaces, utensils, and personnel to prevent cross-contamination.

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

Supplies outside of the ISO 5 Cleanroom hood were not disinfected prior to entering the aseptic processing areas.

The use of sporicidal agents in the aseptic processing area were inadequate.

You performed aseptic processing outside of a certified ISO 5 area.