FDA EIR - Infinity Laboratories LLC - October 29, 2015

An FDA inspection of I-PORA Management dba Infinity Laboratories in Littleton, CO, was conducted from October 26-29, 2015. This comprehensive pre-approval and Current Good Manufacturing Practice (CGMP) inspection, guided by CPs 7356.002 and 7346.832, focused on their control testing laboratory operations, including bioburden, sterility, endotoxin, and microbiological identification. The inspection revealed significant violations in laboratory controls and personnel training. Key issues included inadequate maintenance and testing of the water system used for microbiological media, lacking specifications for water quality (e.g., chlorine and bioburden levels, pH/conductivity ranges). Additionally, validation of sterilization processes for media was deficient, as biological indicators and thermocouples were not placed within the media during autoclaving. The firm also performed growth promotion testing on incoming media lots with an excessive inoculum (>100 CFUs), potentially affecting test sensitivity. Furthermore, devices for sterility testing were not consistently fully submerged in growth media, and reference standards were not routinely checked for expiration dates prior to use. A crucial finding was the absence of continuous and sufficiently frequent CGMP training for employees. An FDA-483 was issued, and Infinity Laboratories promised to implement corrections, specifically committing to establishing a robust CGMP training program.