FDA 483 - Intrathecal Compounding Specialists, LLC

Intrathecal Compounding Specialists, LLC in Scott, LA, a producer of sterile products, was cited for significant deficiencies during an FDA inspection. Observations included producing sterile drugs after air equipment changes without proper cleaning and recertification, inadequate pressure differentials in cleanrooms, and infrequent use of sporicidal agents. Additionally, the firm failed to perform adequate media fills and personnel exhibited improper gowning practices during aseptic operations.