FDA 483 - Intrathecal Compounding Specialists, LLC - August 19, 2021

An FDA 483 inspection conducted from August 9 to August 19, 2021, at Intrathecal Compounding Specialists, LLC, a producer of sterile drug products, identified significant deficiencies in their aseptic processing and environmental control practices. The observations, issued to Operations Manager Dean M. Lamb, indicate potential violations of the Federal Food, Drug, and Cosmetic Act, specifically concerning drug products prepared under insanitary conditions. Key violations included the company's failure to adequately evaluate and remediate actionable microbial contamination found in the ISO 5 classified aseptic processing area. Four instances of contaminated fingertip samples did not result in complete investigations or corrective actions before sterile products were distributed. Furthermore, routine environmental monitoring was deemed insufficient. The inspection also revealed that non-sterile disinfecting agents, cleaning pads, and wipes were used in ISO 5 aseptic processing areas. Cleaning wipes were improperly stored, exposing them to lesser quality air without subsequent decontamination. Finally, the observed disinfectant contact times in both ISO 5 and ISO 7 environments were inadequate, falling short of supplier-recommended dwell times necessary for effective microbial reduction. Intrathecal Compounding Specialists, LLC is expected to implement comprehensive corrective actions to address these critical observations and ensure compliance with regulatory standards for sterile drug production.