FDA 483 - Keybio - March 11, 2022

Keybio, a contract microbiology testing laboratory in La Ciotat, France, was cited for deficiencies in its laboratory controls and employee training. The inspection revealed a lack of written procedures for quantitative microbial enumeration and no periodic spot checks to verify the accuracy of colony counts. Additionally, the firm's training program for microbial testing technicians failed to assess their accuracy in determining viable microbial colonies.