FDA 483 - Intrathecal Compounding Specialists, LLC - February 14, 2019

This FDA Form 483 document details observations made during an inspection of a facility producing and distributing sterile drugs.

A significant observation concerns a change in air equipment within the ISO classified area. On February 6, 2019, the firm replaced the (b)(4) to the sterile suite due to issues with maintaining air coolness. The firm continued to produce and distribute sterile drugs during and after this replacement without adequate cleaning and recertification following the installation.

Additionally, inadequate pressure differentials between higher and lower quality air rooms were observed. Specifically, the buffer room (ISO 7) and anteroom (ISO 8) experienced negative or zero pressure for short periods on January 2, 2019. Furthermore, pressure was lost in the (b)(4) room multiple times on twenty-one days between November 28, 2018, and December 28, 2018. The firm also lacked pressure data for January 24, 2019, to February 7, 2019, between the anteroom and (b)(4) room, including the period when the (b)(4) was being changed.