FDA 483 - Infinity Labs SD, Inc - June 03, 2026

Infinity Labs SD, Inc., a contract sterilizer in San Jose, CA, received a Form 483 citing significant deficiencies in its quality system. Observations included a lack of calibration and verification for critical measuring equipment used in sterilization process verification, as well as inadequate corrective action procedures for assessing the impact of nonconformities on product sterility. These issues raise concerns about the reliability of product quality release decisions and sterility assurance for medical devices.