Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals) – FDA 483, Mar 18, 2019

An FDA Form 483 inspection identified multiple deficiencies at a facility compounding sterile and non-sterile drugs, including P-105 Injection.

**Personnel and Aseptic Processing:** * A pharmacist was observed with exposed skin (gloves not extending over gown sleeves) during aseptic compounding of P-105 Lot #030719@1. * The pharmacist touched surfaces outside the ISO 5 area and re-entered without re-sanitizing gloves. * The pharmacist's hands were completely exposed inside the ISO 5 hood prior to sterile compounding.

**Environmental Control and Disinfection:** * Non-sterile drug components (Phentolamine Mesylate USP, Mannitol USP, Papaverine HCL) and a mixer were not disinfected before entering the ISO 5 aseptic processing area. * The stool in the ISO 7 Cleanroom was covered with a material that could not be adequately disinfected. * Unlabeled bottles of non-sterile isopropyl alcohol were used to disinfect ISO 5 hood surfaces and found in ISO 8 and ISO 7 areas. * The firm failed to validate the sporicidal agent (Spor-Klenz) used in cleanrooms and aseptic processing areas.

**Facility Design and Air Quality:** * Air returns adjacent to HEPA filters in the ISO 8 Anteroom and ISO 7 Cleanroom allowed poor quality air