FDA 483 - Infinity Laboratories LLC - January 07, 2021

Infinity Laboratories LLC in Castle Rock, CO, a contract laboratory, received a Form 483 with four observations. The inspection revealed significant deficiencies in their quality system, including inadequate investigations into unexplained discrepancies and out-of-specification results. Additionally, issues were noted regarding incomplete laboratory records, lack of a data integrity program for electronic data, and insufficient controls for in-process materials and instrument calibration.