Infinity Labs Sd, IncMarch 25, 2025

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

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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.

Company: Infinity Labs Sd, Inc
Inspection Date: March 25, 2025
Product Type: Drugs
Office: San Francisco District Office
People: Darren S. Brown (Consumer Safety Officer)
Jason K. Loo

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ID · d5f257e5-6da8-4997-8bac-262379fb67ab