FDA 483 - Fairview Compounding Pharmacy - April 18, 2018

During an FDA inspection, several deficiencies were observed in sterile drug production. On April 3rd, 2018, non-sterile aluminum foil was used to cover a non-sterile product and transported into an ISO 5 aseptic processing area, where the foil was removed, and processing of Triple Agent UTZ (Papav, Phentol, Alprosst) injectable product (lot #180403-28) continued. Papaverine and phentolamine mesylate stock solutions were produced in an unclassified, non-sterile area, and depyrogenated glassware was stored there.

Inadequate use of sporicidal agents was noted; daily cleaning of ISO 5 aseptic processing areas on April 3rd, 2018, and weekly deep cleaning of ISO 5 and 7 areas on April 6th, 2018, were performed without sporicidal agents. The firm does not regularly use sporicidal agents.

Personnel did not adequately disinfect or change gloves. On April 2nd, 2018, an employee producing allergy serums touched a supply cart in an ISO 7 area and re-engaged in aseptic processing in an ISO 5 hood without changing or sanitizing gloves. Another employee producing Acetylcysteine (PF) 10% Ophthalmic drops (lot #180402-05) repeatedly removed hands from the ISO 5 area