Civic Center Pharmacy, Inc. – FDA 483, Mar 30, 2017

An FDA inspection conducted at Civic Center Pharmacy, Inc. in Scottsdale, AZ, from March 21-30, 2017, resulted in five significant observations documented on a Form FDA 483. The inspection focused on the firm's production of sterile and non-sterile drug products and highlighted several deviations from Current Good Manufacturing Practice (CGMP).

Key issues included a repeat observation of personnel making non-sterile contact with the inner surfaces of drug product containers. The facility also demonstrated inadequate HEPA filter coverage and airflow in areas exposing sterile products, particularly during lyophilization processes. Furthermore, there was an absence of validated sterilization and depyrogenation processes, including hold time studies, for final containers, closures, and tools used in sterile production. Deficiencies in aseptic processing areas, specifically concerning the design of the ISO 8 Prep room's air supply, were also noted. Lastly, batch records for non-sterile drug products often failed to record specific equipment identification, and major equipment lacked physical identification numbers.

In response to these observations, Civic Center Pharmacy, Inc. is required to provide a detailed submission to the FDA outlining the corrective and preventive actions implemented or planned to address each identified deficiency and ensure full compliance with regulatory requirements for drug manufacturing.