Customceutical Compounding, LLC — FDA 483 Findings

Clothing ofpersonnel engaged in the production of drug products intended to be sterile is not appropriate for the duties they perfonn, and personnel donned non-sterile coveralls in a way which might have caused the gowning apparel to become contaminated.

Aseptic processing areas are deficient regarding the systems for environmental monitoring conditions and actionable microbial contamination was present in the ISO 5 area or in adjacent areas during aseptic production without adequate product evaluation and remedial action.

Your firm produced hazardous drug products using shared equipment and utensils, and there was inadequate containment and segregation to prevent cross--contamination of non-sterile drug products.