FDA WARNING_LETTER - American Preclinical Services - April 13, 2018

This Warning Letter, dated February 12, 2019, addresses objectionable conditions observed during an FDA inspection of American Preclinical Services, LLC from March 19 to April 13, 2018. The inspection assessed compliance with Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies (21 CFR Part 58) for studies involving devices.

Key violations include: 1. **Failure of the study director to fulfill responsibilities (21 CFR 58.33):** Examples include not taking corrective action for animal deaths and unexpected findings (e.g., ventilator misuse, tissue infarcts), failing to ensure protocol adherence (e.g., ACT evaluation frequency, device retention), and not ensuring transfer of all raw data, documentation, and reports to archives. 2. **Failure of the Quality Assurance Unit (QAU) to fulfill responsibilities (21 CFR 58.35):** The QAU failed to identify issues such as surgical technicians performing anesthesia outside required parameters, lack of timely veterinary review of clinical pathology data, and improper labeling of necropsy and tissue trim images. 3. **Failure to ensure proper animal identification and water analysis (21 CFR 58.90):** Inadequate animal identification on housing units and failure to follow SOPs for periodic water analysis were noted, including not analyzing water samples from one facility in 2016 and only analyzing main