North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding — FDA 483 Findings

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

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

Non-sterilized equipment was used in sterile drug production.

Smoke studies performed under dynamic conditions are inadequate.

You used a non-pharmaceutical grade component in the formulation of a drug product.

Failure to conduct media fills that closely simulates aseptic compounding operations under the worst case, most challenging and stressful conditions.

The <Redacted B4> intended to render final product sterile was not pharmaceutical grade.

You produced highly potent drugs without providing adequate containment to prevent cross­contamination.