FDA 483 - Medicilon Preclinical Research (Shanghai) LLC - October 21, 2024

Medicilon Preclinical Research, Inc. in Shanghai, China, a nonclinical laboratory, was cited for significant deficiencies during an FDA inspection. Observations included poorly maintained animal housing and storage areas, inadequate standard operating procedures for critical lab processes, and failures in archive indexing and quality assurance documentation. These issues indicate a lack of control over facility conditions, study methods, and record-keeping, which could impact the quality and integrity of nonclinical laboratory studies.