Excite Pharma Services, LLC – FDA EIR, Oct 10, 2023

An FDA inspection of Excite Pharma Services, LLC's Tonganoxie, KS facility was conducted on October 10, 2023. This routine surveillance and pre-approval inspection, governed by regulatory framework CP 7368.001 for new animal drug applications, aimed to assess the drug manufacturer's readiness for commercial production. The facility primarily produces sterile animal and human drugs for Phase 1 and 2 clinical trials. The inspection concluded without an FDA Form 483 (Inspectional Observations) being issued, but significant issues were identified, leading to a determination that the firm lacked readiness for commercial manufacturing. Key concerns included a large volume fill line being out of service for extensive improvements and requiring requalification. Inspectors also noted several operational deficiencies: inadequate physical separation and environmental monitoring in the warehouse; an inoperable water system; improper storage of clean equipment; and the absence of a dedicated vial washer/dryer. Additionally, the low volume fill suite presented potential contamination risks due to unsealed ceiling tiles and an inadequately capped floor drain, along with suboptimal personnel pathways. Management acknowledged these deficiencies. While no specific regulatory actions were mandated via a 483, the firm is required to address all identified issues to achieve commercial readiness and ensure compliance with good manufacturing practices before product distribution.