483
Infinity Labs Sd, IncInfinity Labs Sd, Inc – FDA 483, Mar 25, 2025
Record Details
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.
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ID · d5f257e5-6da8-4997-8bac-262379fb67ab
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