During 2013 the MHRA performed 174 inspections in the UK and 42 overseas. The top 5 categories where the most defects were observed are:
• Investigation in anomalies
• Quality Management
• CAPA
• Contamination, physical/chemical
• Supplier and contract audit
These categories have remained relatively consistent with exception of “Contamination, physical/chemical” which has significantly increased.

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MHRA_Deficiencies2013