FDA 483 - Saptalis Pharmaceuticals LLC - March 17, 2023

Saptalis Pharmaceuticals LLC in Hauppauge, NY, received a Form 483 with four observations during an inspection from March 9-17, 2023. The firm was cited for significant deficiencies including inadequate computer system controls allowing data deletion, insufficient written procedures for component testing, deficient in-process material testing and bulk hold time studies, and improper quarantine of rejected drug product containers. These findings highlight critical issues in data integrity, quality control, and material management practices.