The FDA’s emphasis on laboratory audits in recent years has focused on companies confirming that laboratory data is not fraudulent. With the rise in evidence that justifies the FDA’s fraudulent data concerns — especially internationally — the failure of companies to provide established historical information and ensure compliance on the validation of their analytical methods…
Avoid an FDA Warning Letter in the Laboratory Environment
The FDA’s emphasis on laboratory audits in recent years has focused on companies confirming that laboratory data is not fraudulent.