Pharmacy Plus, Inc. dba Vital Care Compounder — FDA 483 Findings

You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.

The final containers/closures used for drug product intended to be sterile were not sterilized an <Redacted B4> i - · Specifically, your firm conducted a <Redacted B4> study on 9/30/22 for the <Redacted B4>.

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

You produced hazardous drugs without providing adequate segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.

Disinfecting agents and cleaning pads and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.

The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or surface.

The cycle parameters, <Redacted B4> used for <Redacted B4> sterilization of product intended to be sterile were not lethal to heat-resistant microorganisms.

Personnel used a non-sterile tool on and manually contacted the inner surface of the container or closure.

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.