BASi® has an outstanding regulatory record. You will be more confident in meeting your targets and having a successful review and audit of your data by working with our experienced scientific team.
All of our facilities are inspected by the U.S Food and Drug Administration (FDA). Unannounced inspections have always resulted in either no findings or have required voluntary actions for correction. Those steps are documented in a form 483. To date, all of BASi®’s responses to 483s have been accepted by the FDA, resulting in no further action.