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

During an inspection conducted from March 24-25, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Infinity Labs Sd, Inc, a control testing laboratory located in Petaluma, CA. The inspection revealed two primary observations indicating non-adherence to regulatory expectations.

Firstly, the firm's quality control unit was found not to be fully following its established responsibilities and procedures. Specifically, Infinity Labs Sd, Inc failed to adhere to its own standard operating procedures (SOPs) for instrument calibration related to critical endotoxin testing ("LAL Testing") and DNASE/RNASE detection. Instruments for these tests were not calibrated at the frequencies specified in the firm's SOPs, with one last calibrated in April 2024 and another in December 2023, contrary to their internal schedules.

Secondly, issues were identified within the facility’s infrastructure. The Bioburden Room was observed to have missing and stained ceiling tiles, indicating that the building construction or maintenance was not suitable to facilitate proper cleaning and operations.

These observations highlight deviations from current regulatory standards governing quality systems and facility controls for laboratories. Infinity Labs Sd, Inc is now required to address these findings by developing and implementing comprehensive corrective and preventive actions to ensure compliance with its own procedures and broader regulatory requirements.