Description - Figure 2.2.2 Sections of the Food and Drugs Regulations against which Risk 1 observations were cited by Fiscal Year (April 1, 2006 - March 31, 2011) - Summary report of the Drug Good Manufacturing Practices (GMP) Inspection Program - April 1, 2006 to March 31, 2011

From April 1, 2006 to March 31, 2007 there was 1 observation noted against the Regulations covering quality control department and 1 observation noted against the Regulations covering records which were rated as Risk 1 observations.

From April 1, 2007 to March 31, 2008 there was 1 observation noted against the Regulation covering equipment, there was 1 observation noted against the Regulation covering personnel, there was 1 observation noted against the Regulations covering raw material testing, there was 1 observation noted against the Regulations covering manufacturing control, there was 1 observation noted against the Regulations covering quality control department, there was 1 observation noted against the Regulations covering finished product testing and 1 observation noted against the Regulations covering records which were rated as Risk 1 observations.

From April 1, 2008 to March 31, 2009 there was 1 observation noted against the Regulation covering personnel, there were 2 observations noted against the Regulations covering raw material testing, there was 1 observation noted against the Regulations covering manufacturing control, there was 1 observation noted against the Regulations covering finished product testing, there were 2 observations noted against the Regulations covering records and there were 4 observations noted against the Regulations covering sterile products which were rated as Risk 1 observations.

From April 1, 2009 to March 31, 2010 there were 4 observations noted against the Regulation covering premises , there was 1 observation noted against the Regulation covering equipment,there were 2 observations noted against the Regulations covering manufacturing control, there were 9 observations noted against the Regulations covering quality control department, there were 3 observations noted against the Regulations covering finished product testing, were 2 observations noted against the Regulations covering records, there was 1 observation noted against the Regulations covering stability and 21 observations noted against the Regulation covering sterile products which were rated as Risk 1 observations.

From April 1, 2010 to March 31, 2011 there was 1 observation noted against the Regulations covering sanitation , there was 1 observation noted against the Regulations covering raw material testing, there were 4 observations noted against the Regulations covering manufacturing control, there were 7 observations noted against the Regulations covering quality control department, there was 1 observation noted against the Regulations covering finished product testing, were 3 observations noted against the Regulations covering records, were 2 observations noted against the Regulations covering stability and 4 observations noted against the Regulation covering sterile products which were rated as Risk 1 observations.