# FDA 483 - Infinity Labs Sd, Inc - March 25, 2025

Source: https://www.keypedia.com/records/483/infinity-labs-sd-inc/d5f257e5-6da8-4997-8bac-262379fb67ab

> FDA 483 for Infinity Labs Sd, Inc on March 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infinity Labs Sd, Inc
- Inspection Date: 2025-03-25
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: Infinity Labs Sd, Inc, a control testing laboratory in Petaluma, CA, was cited for significant quality control and facility maintenance deficiencies. The firm failed to follow its own SOPs for critical testing calibrations, including endotoxin and DNASE/RNASE detection. Additionally, the facility's Bioburden Room exhibited unsuitable construction with missing and stained ceiling tiles, hindering proper cleaning and operations.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)
- [Jason K. Loo](https://www.keypedia.com/people/jason-k-loo/7977c92f-c40e-45af-a072-f84361045a47)

Company: https://www.keypedia.com/companies/infinity-labs-sd-inc/17c6a940-0b9a-45a1-8310-0dd0ee06f872

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