FDA 483 - Q LABS, LLC - April 25, 2025

Q LABS, LLC, a contract testing laboratory in Cincinnati, was cited for significant deficiencies in its quality control unit. The inspection revealed inadequate investigations into out-of-specification results and non-conformances, as well as a failure to ensure proper second-person review of microbiology laboratory records. These issues indicate a lack of thoroughness in their quality system for drug product testing.