FDA 483 - Infinity Labs Sd, Inc - March 25, 2025

Infinity Labs Sd, Inc, a control testing laboratory in Petaluma, CA, was cited for significant quality control and facility maintenance deficiencies. The firm failed to follow its own SOPs for critical testing calibrations, including endotoxin and DNASE/RNASE detection. Additionally, the facility's Bioburden Room exhibited unsuitable construction with missing and stained ceiling tiles, hindering proper cleaning and operations.