FDA 483 - Altasciences Preclinical Seattle, LLC - July 18, 2025

During an inspection conducted by the FDA from July 14-18, 2025, Altasciences Preclinical Seattle, LLC, a nonclinical laboratory, received an FDA Form 483 citing two significant observations. The first observation indicated that testing facility management failed to ensure all personnel clearly understood their roles. This deficiency manifested in multiple instances where animal tissues (including tongue, thymus, vagina, and brain components) were documented as missing during histology processing for studies ALN-CFB-TX-23067 and LYT-310-2023-NC-003, despite being observed as normal by the study pathologist. This highlights a critical breakdown in procedural adherence and communication regarding specimen handling. The second observation concerned inadequate specimen identification. For studies 2022-004-DISC-0974-MK-TK-GLP and 2025-PH-124, specimens of serum and blood in archive storage or undergoing collection lacked the date of collection on their containers or accompanying documentation. This omission creates a risk of error in data recording and storage, compromising data integrity and traceability. These observations suggest a need for improved quality systems and adherence to established practices, aligning with regulatory expectations for nonclinical laboratories. Altasciences Preclinical Seattle, LLC is expected to review these findings and respond to the FDA with proposed corrective actions to address the identified deficiencies.