483
Saptalis Pharmaceuticals LLCFDA 483 - Saptalis Pharmaceuticals LLC - March 17, 2023
Record Details
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.
Open in Dashboard
ID · b3f0de28-46f4-4f38-9983-f3f5a79aa93f