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

Source: https://www.globalkeysolutions.net/records/483/infinity-labs-sd-inc/f95bfefb-a427-473a-a9ac-b075578c11f2

> FDA 483 for Infinity Labs SD, Inc on August 21, 2023. Product: device. 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: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Infinity Labs SD, Inc., a contract sterilizer in San Jose, CA, received a Form FDA 483 for inadequate documentation of corrective and preventive action (CAPA) activities. The inspection found that CAPA investigations frequently attributed issues to "operator error" without adequately documenting reviews of products, processes, or the overall quality system. This deficiency indicates a need for more thorough root cause analysis and documentation within the firm's quality management system.

## Related Documents

- [483 - 2023-08-21](https://www.globalkeysolutions.net/records/483/infinity-labs-sd-inc/00c752ce-4686-41fe-92b1-3a1f2ae15ffb)
- [483 - 2023-08-21](https://www.globalkeysolutions.net/records/483/infinity-labs-sd-inc/7ef71a98-9cea-453f-bb2f-c49f70aae83f)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b