Med Shop Total Care Inc. — 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.

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

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

Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worse-case activities and conditions that provide a challenge to aseptic operations.

Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which purports or is represented to possess.

Non-microbial contamination was observed in your production area.

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.