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

Source: https://www.keypedia.com/records/483/infinity-labs-sd-inc/00c752ce-4686-41fe-92b1-3a1f2ae15ffb

> FDA 483 for Infinity Labs SD, Inc on August 21, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infinity Labs SD, Inc
- Inspection Date: 2023-08-21
- Product Type: Devices
- Office Name: San Francisco District Office
- Summary: During an FDA inspection conducted from August 17 to August 21, 2023, at Infinity Labs SD, Inc., located at 1836 Stone Ave, San Jose, CA, several compliance issues were identified. The facility, a contract sterilizer, was found to have inadequately documented corrective and preventive action (CAPA) activities. Specifically, the inspection revealed that four out of seven reviewed CAPA cases were attributed to "operator error" without sufficient documentation of product, process, or quality system reviews.

The specific cases included CAPA #22003, #22005, #22008, and #23003, which involved issues such as cracked external process challenged devices, improper mixing of catheters, incorrect use of Ethylene Oxide, and errors in repacking customer products. In each instance, the root cause was identified as operator error, and the proposed corrective action was group training for the operators. However, the company failed to document any further investigation into processes or quality systems that might contribute to these errors.

Under the Federal Food, Drug, and Cosmetic Act, Infinity Labs SD, Inc. is required to conduct internal audits to identify and rectify all quality system violations. The FDA emphasized the importance of documenting comprehensive investigations beyond attributing issues to operator error. Infinity Labs SD, Inc. has promised to address these observations. The company is expected to implement corrective actions and improve documentation practices to ensure compliance with FDA regulations.

## Related Documents

- [483 - 2023-08-21](https://www.keypedia.com/records/483/infinity-labs-sd-inc/7ef71a98-9cea-453f-bb2f-c49f70aae83f)
- [483 - 2023-08-21](https://www.keypedia.com/records/483/infinity-labs-sd-inc/f95bfefb-a427-473a-a9ac-b075578c11f2)

## Related Officers

- [Kenya Destin](https://www.keypedia.com/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.keypedia.com/companies/infinity-labs-sd-inc/b3d37efd-15bd-4a45-a9ff-a1a55fe570bb

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df