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

This FDA Form 483 was issued to Intrathecal Compounding Specialists, LLC, a producer of sterile products located at 206A Jacob's Run, Scott, LA 70583, following an inspection conducted from February 6-8 and 14, 2019.

The inspection revealed five observations related to quality system and manufacturing issues.

Observation 1 notes that the ISO classified area's air equipment was changed on February 6, 2019, due to issues maintaining air coolness. The firm continued to produce and distribute sterile drugs without adequate cleaning and recertification after the replacement.

Observation 2 identifies inadequate pressure differentials. Negative or zero pressure was observed in the buffer room (ISO 7) and anteroom (ISO 8) on January 2, 2019, and pressure was lost multiple times in another room from November 28 to December 28, 2018. No pressure data was available for January 24 to February 7, 2019, including during the air equipment change.

Observation 3 states that the use of sporicidal agents in cleanrooms and the ISO 5 area is inadequate, specifically, a sporicidal cleaner is not used at a minimum monthly.

Observation 4 indicates that media fills did not adequately simulate aseptic production operations, lacking worst-case activities and conditions. Media fills included