FDA 483 - Civic Center Pharmacy, Inc. - October 09, 2014

On October 9, 2014, the FDA issued a Form 483 to Civic Center Pharmacy in Scottsdale, AZ, following an inspection conducted from September 10 to October 9, 2014. The facility, managed by Tenille D. Davis, Pharm D., RPh, is a producer of sterile drug products.

The inspection revealed two primary observations:

**Observation 1: Deficient Environmental Monitoring in Aseptic Processing Areas** The firm's system for monitoring environmental conditions in ISO 5 and ISO 7 cleanroom environments, used for sterile drug product production, does not represent actual conditions during active processing. * **Viable Particulate Air Monitoring:** Not routinely conducted during active aseptic processing in ISO 5 hoods or the ISO 7 cleanroom. It is only performed every six months by an outside contractor. * **Non-Viable Particulate Air Monitoring:** Not routinely conducted during active aseptic processing in ISO 5 hoods or ISO 7 environments. It is only performed every six months by an outside contractor. * **Cleanroom Pressure Differentials:** Not actively monitored during aseptic processing. Manual readings are taken only once per day before production under static conditions, with no further monitoring during production. * **Surface Environmental Monitoring:** Not adequate to represent actual conditions. Conducted weekly, but the sampling method was not fully detailed. * **Personnel Monitoring:** Not routinely conducted for