FDA 483 - Q LABS, LLC - November 21, 2019

Q Laboratories Inc, a control laboratory in Cincinnati, OH, was cited for failing to fully follow its quality control unit procedures. Specifically, the firm did not close out-of-specification (OOS) investigations within the required timeframe and lacked proper justification documentation for extensions, as mandated by its own SOPs. This indicates deficiencies in their quality system and adherence to internal protocols.