# Infinity Labs SD, Inc – FDA 483, Jun 3, 2026

Source: https://www.keypedia.com/records/483/infinity-labs-sd-inc/9b91316d-6de1-48a1-ab80-4bae37cb9328

> FDA 483 for Infinity Labs SD, Inc on June 03, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infinity Labs SD, Inc
- Inspection Date: 2026-06-03
- Product Type: device
- Office Name: San Francisco District Office
- Summary: 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.

## Related Documents

- [483 - 2025-03-25](https://www.keypedia.com/records/483/infinity-labs-sd-inc/ac8a62a8-fd31-4b77-a2e6-c13914a89fae) — date: March 25, 2025
- [483 - 2023-08-21](https://www.keypedia.com/records/483/infinity-labs-sd-inc/00c752ce-4686-41fe-92b1-3a1f2ae15ffb) — date: August 21, 2023

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

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