FDA 483 - Fairview Compounding Pharmacy - April 18, 2018

An FDA inspection of Fairview Compounding Pharmacy, a producer of sterile and non-sterile products located at 711 Kasota Ave SE, Minneapolis, MN, was conducted from April 2, 2018, to April 18, 2018. The inspection identified six observations regarding the firm's operations.

Observation 1 noted the use of non-sterilized and non-depyrogenated equipment in sterile drug production. Specifically, non-sterile aluminum foil was used to cover a non-sterile product and transported into the ISO 5 aseptic processing area, where it was removed, and aseptic processing of Triple Agent UTZ injectable product (lot #180403-28) continued. Papaverine and phentolamine mesylate stock solutions were produced in an unclassified non-sterile area, and depyrogenated glassware was also stored there.

Observation 2 indicated inadequate use of sporicidal agents in cleanrooms and the ISO 5 aseptic processing area. Cleaning of ISO 5 areas on April 3rd, 2018, and deep cleaning of ISO 5 and 7 areas on April 6th, 2018, were performed without sporicidal agents, and the firm does not use them regularly.

Observation 3 detailed instances where personnel did not disinfect and change gloves frequently enough. On April 2, 2018, an employee producing allergy