Inventive Infusion Solutions, LP — FDA 483 Findings

Personnel did not disinfect to prevent contamination Specifically, On 8/22/2018 and 8/28/2018, operator <Redacted B4> was observed with exposed facial skin while cleaning the surfaces in side the ISO 5 area of <R edacted B4> Hood.

Disinfecting agents and used in the ISO 5 classified aseptic processing areas were note sterile.

Unsealed, loose ceiling tiles were observed in your cleanroom.

Biological indicators are not used properly to verify the adequacy ofthe sterilization cycle.

You produced beta-lactam drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning ofutensils and cleaning of personnel to prevent cross-contamination.

Non-sterilized and Non-depyrogenated equipment was used in sterile drug production.

Endotoxin level is not tested on the finished drug products.

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.