FDA 483 - Certified Laboratories LLC - May 20, 2022

Certified Lab Dallas, LLC. dba Microconsult, Inc, a contract testing laboratory in Carrollton, TX, was cited for significant deficiencies across its laboratory and facility systems. Observations included unvalidated in-house test methods, widespread issues with laboratory record integrity and data control, and poor facility maintenance. The findings indicate a lack of robust quality control and adherence to established procedures.