FDA 483 - Certified Laboratories LLC - January 31, 2025

Certified Laboratories LLC in Carrollton, TX, a contract testing laboratory, was cited for deficient laboratory records during an FDA inspection. The firm failed to maintain complete data for testing, specifically regarding multiple instances of aborted test runs on laboratory equipment without proper justification or documentation. Furthermore, the firm lacked established written procedures for authorizing, reporting, and documenting such aborted runs, raising concerns about data integrity and quality control.