FDA 483 - University Rx Specialist, dba University Compounding Pharmacy - October 27, 2017

During an FDA inspection, it was observed that non-depyrogenated equipment was used in the production of sterile drugs. Specifically, the firm does not depyrogenate the (b)(4) that come into direct product contact during the mixing of drug components in the ISO 8 Ante-Room 2.

On October 19, 2017, a technician was observed using these non-depyrogenated (b)(4) in the production of several batches of Bi-Mix (Phentolamine/Papaverine) 2mg-30mg/ML Inj. The affected product batches and their expiration dates are: * (b)(4) 762803, expiring 1/26/2018 * (b)(4) 762818, expiring 1/26/2018 * (b)(4) 762823, expiring 1/26/2018 * (b)(4) 762806, expiring 1/26/2018

This observation indicates a deficiency in the firm's quality system and manufacturing controls related to equipment sterilization and pyrogen removal for sterile drug production, potentially impacting product sterility and patient safety.