Sharp Drugs, Inc. — FDA 483 Findings

Materials or supplies were not disinfected prior to entering the aseptic processing area Specifically, <Redacted B4> and Deferoxamine 2gm vials are not disinfected prior to being brought into the aseptic processing area for product io n of Deferoxamine 2.5gm IV .

Environmental monitoring was not performed in your aseptic processing areas

Disinfecting agents, cleaning pads, and cleaning wipes used in the ISO 5 classified aseptic processing area were not sterile Specifically, the only disinfecting agent used to clean the biological safety cabinet is <Redact ed B4> which is applied with non-sterile, disposable paper towels.

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 Specifically you have not performed any media fills.

Personnel engaged in aseptic processing wear non-sterile gloves Specifically, t he only personnel protective equipment worn by the owner, who performs all of the steri le processing, is non-s terile, nitrile gloves.