FDA and MHRA Most Recent Inspection Observations
Part of a comprehensive GMP Intelligence program is the monitoring of enforcement actions, including FDA 483s, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent GMP inspection data from CDER and MHRA. The CDER data are from inspections conducted in FY2016 and the MHRA data […]