We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The firm’s recordkeeping made it unclear if the issues described in customer complaints represented adverse events that should have been reported to the FDA. Read More
None of the company’s complaints from 2016 or 2017 reviewed by the FDA had been evaluated to determine whether they should be reported to the agency as adverse events. Read More
Westone Laboratories’ manufacturing facility in Oregon drew a Form 483 from the FDA for significant quality system nonconformities and equipment calibration issues. Read More
Palo Alto Health Sciences drew a Form 483 from the FDA for inadequate CAPA and complaint procedures, and for incomplete internal auditing and supplier profiles. Read More
The SynchroMed II application provides visual tools, such as flex dosing graphics, and guided workflows, with the goal of simplifying treatment management. Read More