Part of a comprehensive GMP Intelligence program is the monitoring of enforcement actions, including FDA forms-483, 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 come from inspections conducted in 2015.
The CDER drug inspection observations supplement the information we previously published regarding CDER Drug GMP warning letters from the same time. The analysis herein includes data from the FY2016 form-483 observations and compares results with those from the three previous fiscal years. READ MORE….