FDA 483 - Infinity Labs SD, Inc - August 21, 2023

On August 21, 2023, the FDA issued a Form 483 to Infinity Labs SD, Inc., a contract sterilizer located at 1836 Stone Ave, San Jose, CA. The inspection, conducted from August 17-21, 2023, identified one observation regarding the firm's quality system.

The primary observation noted was that corrective and preventive action (CAPA) activities and/or results have not been adequately documented. Specifically, the CAPA investigation activities were found to be insufficiently documented. Four out of seven reviewed CAPAs attributed the root cause to "operator error" without documenting any review of product, processes, or the quality system as part of the investigation.

Examples cited include: 1. **CAPA #22003 (2/14/22):** Opened for a cracked external process challenged device (ePCD) post-sterilization. Root cause identified as operator handling, with a plan for group training. 2. **CAPA #22005 (4/21/2022):** Opened due to a customer complaint about mixed catheters post-sterilization. Root cause identified as operator error, with a plan for group training on re-packaging per customer instructions and FRM 0026. 3. **CAPA #22008 (8/22/2