FDA Slams Teligent For Lax Approach To Complaint Handling And Stability Testing
Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
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Glenmark, which has been the recipient of a string of notices from the US Food and Drug Administration over manufacturing quality issues, is again under fire with the regulator blasting the leading Indian drugmaker for failing to ensure “consistent production” of safe and effective products.
As it prepares to start injectables filings from its facility in Buena, New Jersey, Teligent is putting in place its senior operational and quality functions.
US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.