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Drug Recalls and Warning Letters - Increasing Numbers Caused by Manufacturing Errors and Regulatory Non-compliance Issues

GBI Research
Published Date » 2011-11-07
No. Of Pages » 128

GBI Researchs report, Drug Recalls and Warning Letters - Increasing Numbers Caused by Manufacturing Errors and Regulatory Non-compliance Issues, provides in-depth analysis of Warning Letters, drug recalls issued or reported with the US Food and Drug Administration (FDA) and its constituent agencies. The report analyzes warning letters from the issuing agencies and reason for these warning letters. The report contains year by year detailed analysis about warning letters issued for various reasons by regulatory authorities. The report is built on data and information sourced from the FDA database of warning letters and drug recalls and in-house analysis by GBI Researchs team of industry experts.

GBI Research indicates that the warning letters and drug recalls have significantly increased during 2007-2010, due to various underlying causes which are explained in detail in the report. The report also provides analysis of warning letters individually issued by the Center for Drug Evaluation (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM). 

The increase in the number of warning letters can be attributed to manufacturing defects present in recalled products. In the report, detailed analysis of recalled products, with the year of recall, recalling firm, dosage form, therapy area, reason for recall and the subset reason for recalls, is provided. 

The report presents the year by year drug recall analysis by the recalling firms along with the reason for recall. In the analysis Class I drug recalls have been specially covered, while analysis for other types of recall have also been made. The report analyzes the percentage distribution of drug recalls in terms of dosage form, therapy area and other areas.

Scope

  • The data and numerical figures on the number of warning letters and drug recalls issued according to the year of recall, recalling firm, and reporting FDA agency for 2007-2010.
  • Analysis of leading therapeutic areas and dosage forms for major drug recalls were issued
  • Analysis of reasons for recall, along with in-depth analysis of underlying reasons and showing its pattern from 2007-2010.
  • In this report the warning letters and drug recalls were analyzed by drug class of the recalled drug products.

Reasons to buy

  • Understand the pattern of warning letters and drug recalls, along with their underlying causes, so as to enable you to undertake various strategies in order to protect products from encountering safety issues.
  • To analyze the major reasons for recall, along with the therapy areas and class of recalled drugs most vulnerable, so as to strengthen the areas which may lead to quality defects in your companys products.
  • Reinforce quality and manufacturing strategies so as to be complaint with the current regulatory norms.
  • Develop key strategic initiatives by understanding the key focus areas of the warning letters and drug recalls.
Table of Contents

1 Table of Contents

1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6

2 Drug Recalls and Warning Letters - Introduction 8
2.1 Report Guide 9

3 Warning Letters - An Overview 10
3.1 Boxed Warning 11

4 Warning Letters - Trend Analysis 12

4.1 Warning Letters Reported by FDA Agency by Year 12
4.1.1 Warning Letters Reported by CDER 13
4.1.2 Warning Letters Reported by CBER 34
4.1.3 Warning Letters Reported by CDRH 38
4.1.4 Warning Letters Reported by CFSAN 39
4.1.5 Warning Letters Reported by CVM 40
4.2 Warning Letters Reported by FDA Agency by Reason 41
4.2.1 Warning Letters Reported by FDA Agency by Reason, 2010 43
4.2.2 Warning Letters Reported by FDA Agencies by Reason, 2009 44
4.2.3 Warning Letters Reported by FDA Agencies by Reason, 2008 45
4.2.4 Warning Letters Reported by FDA Agencies by Reason, 2007 46
4.3 Warning Letters by Reason by Year 47
4.3.1 Warning Letters Reported for Regulatory Errors 47
4.3.2 Warning Letters Reported for Clinical Research Errors 48
4.3.3 Warning Letters Reported for Marketing Errors 49
4.3.4 Warning Letters Reported for Manufacturing Errors 50
4.3.5 Warning Letters Reported for Quality Errors 51
4.4 Warning Letters by Year by FDA Agency 52
4.4.1 Warning Letters Reported by FDA Agency in 2007 52
4.4.2 Warning Letters Reported by FDA Agency in 2008 53
4.4.3 Warning Letters Reported by FDA Agency in 2009 54
4.4.4 Warning Letters Reported by FDA Agency in 2010 55

5 Drug Recalls - An Overview 56
5.1 Types of Drug Recalls 56
5.2 Reasons of Drug Recalls 57
5.3 Drug Recall Process 57
5.4 Drug Recalls Reported by CDER 59
5.5 Drug Recalls Reported by CBER 61

6 Drug Recalls - Trend Analysis 64
6.1 Analysis of Drug Recalls 2007-2010 64
6.1.1 Reasons for Drug Recall 76
6.1.2 Drug Recalls by Product Class 77
6.1.3 Drug Recalls by Different Dosage Forms 78
6.1.4 Drug Recalls by Companies 79
6.1.5 Drug Recalls by Drug Class 81
6.1.6 Drug Recalls by Therapy Area 83
6.2 Analysis of Drug Recalls 2007 85
6.2.1 Drug Recalls by Therapy Area, 2007 85
6.2.2 Drug Recalls by Drug Class, 2007 86
6.2.3 Drug Recalls by Product Class, 2007 87
6.2.4 Drug Recalls by Dosage Form, 2007 88
6.2.5 Drug Recalls by Companies, 2007 89
6.2.6 Reasons for Drug Recalls, 2007 90
6.3 Analysis of Drug Recalls 2008 93
6.3.1 Drug Recalls by Therapy Area, 2008 93
6.3.2 Drug Recalls by Drug Class, 2008 95
6.3.3 Drug Recalls by Product Class, 2008 97
6.3.4 Drug Recalls by Dosage Form, 2008 98
6.3.5 Drug Recalls by Companies, 2008 99
6.3.6 Reasons for Drug Recalls, 2008 101
6.4 Analysis of Drug Recalls 2009 104
6.4.1 Drug Recalls by Therapy Area, 2009 104
6.4.2 Drug Recalls by Drug Class, 2009 106
6.4.3 Drug Recalls by Product Class, 2009 107
6.4.4 Drug Recalls by Dosage Form, 2009 108
6.4.5 Drug Recalls by Companies, 2009 110
6.4.6 Reasons for Drug Recalls, 2009 111
6.5 Analysis of Drug Recalls 2010 114
6.5.1 Drug Recalls by Therapy Area, 2010 114
6.5.2 Drug Recalls by Drug Class, 2010 116
6.5.3 Drug Recalls by Product Class, 2010 118
6.5.4 Drug Recalls by Dosage Form, 2010 119
6.5.5 Drug Recalls by Companies, 2010 120
6.5.6 Reasons for Drug Recalls, 2010 121
6.6 Analysis of Top Reasons for Drug Recalls, 2007-2010 124
6.6.1 Drug Recalls Reported due to Manufacturing Errors 124
6.6.2 Drug Recalls Reported due to Quality Defects 125

7 Drug Recalls and Warning Letters - Appendix 126
7.1 Market Definitions 126
7.2 Abbreviations 126
7.3 Research Methodology 126
7.3.1 Coverage 126
7.3.2 Warning Letters An Overview 127
7.3.3 Warning Letters Trend Analysis 127
7.3.4 Drug Recalls An Overview 127
7.3.5 Drub Recalls Trend Analysis 127
7.4 Contact Us 128
7.5 Disclaimer 128
7.6 Sources 128

List of Tables


Table 1: Drug Recalls and Warning Letters , List of Warning Letters Reported by CDER, 2010 14
Table 2: Drug Recalls and Warning Letters, List of Warning Letters Reported by CDER, 2009 20
Table 3: Drug Recalls and Warning Letters, List of Warning Letters Reported by CDER, 2008 29
Table 4: Drug Recalls and Warning Letters, List of Warning Letters Reported by CDER, 2007 31
Table 5: Drug Recalls and Warning Letters, List of Warning Letters Reported by CBER, 2010 35
Table 6: Drug Recalls and Warning Letters, List of Warning Letters Reported by CBER, 2009 35
Table 7: Drug Recalls and Warning Letters, List of Warning Letters Reported by CBER, 2008 37
Table 8: Drug Recalls and Warning Letters, List of Warning Letters Reported by CBER, 2007 37
Table 9: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2007-2010 41
Table 10: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2010 43
Table 11: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2009 44
Table 12: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2008 45
Table 13: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2007 46
Table 14: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency (%), 2007 52
Table 15: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency (%), 2008 53
Table 16: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency (%), 2009 54
Table 17: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency (%), 2010 55
Table 18: Drug Recalls and Warning Letters, List of Analyzed Drug Recalls, 2007 65
Table 19: Drug Recalls and Warning Letters, List of Analyzed Drug Recalls, 2008 66
Table 20: Drug Recalls and Warning Letters, List of Analyzed Drug Recalls, 2009 70
Table 21: Drug Recalls and Warning Letters, List of Analyzed Drug Recalls, 2010 73
Table 22: Drug Recalls and Warning Letters, Number of Drug Recalls by Reason for Recall, 2007-2010 76
Table 23: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form, 2007-2010 78
Table 24: Drug Recalls and Warning Letters, Drug Recalls by Companies, 2007-2010 79
Table 25: Drug Recalls and Warning Letters, Drug Recalls by Drug Class, 2007-2010 81
Table 26: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area, 2007-2010 83
Table 27: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area, 2007 85
Table 28: Drug Recalls and Warning Letters, Drug Recalls by Drug Class, 2007 86
Table 29: Drug Recalls and Warning Letters, Drug Recalls by Product Class, 2007 87
Table 30: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form, 2007 88
Table 31: Drug Recalls and Warning Letters, Drug Recalls by Companies, 2007 89
Table 32: Drug Recalls and Warning Letters, Drug Recalls by Reason for Recall, 2007 90
Table 33: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area, 2008 93
Table 34: Drug Recalls and Warning Letters, Drug Recalls by Drug Class, 2008 95
Table 35: Drug Recalls and Warning Letters, Drug Recalls by Product Class (%), 2008 97
Table 36: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form, 2008 98
Table 37: Drug Recalls and Warning Letters, Drug Recalls by Companies, 2008 99
Table 38: Drug Recalls and Warning Letters, Drug Recalls by Reason for Recall, 2008 101
Table 39: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area, 2009 104
Table 40: Drug Recalls and Warning Letters, Drug Recalls by Drug Class, 2009 106
Table 41: Drug Recalls and Warning Letters, Drug Recalls by Product Class, 2009 107
Table 42: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form, 2009 108
Table 43: Drug Recalls and Warning Letters, Drug Recalls by Companies (%), 2009 110
Table 44: Drug Recalls and Warning Letters, Drug Recalls by Reason for Recall, 2009 111
Table 45: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area, 2010 114
Table 46: Drug Recalls and Warning Letters, Drug Recalls by Drug Class (%), 2010 116
Table 47: Drug Recalls and Warning Letters, Drug Recalls by Product Class, 2010 118
Table 48: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form, 2010 119
Table 49: Drug Recalls and Warning Letters, Drug Recalls by Companies, 2010 120
Table 50: Drug Recalls and Warning Letters, Drug Recalls by Reason for Recall, 2010 121

List of Figures


Figure 1: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agencies by Year, 2007 2010 12
Figure 2: Drug Recalls and Warning Letters, Warning Letters Reported by CDER, 2007-2010 13
Figure 3: Drug Recalls and Warning Letters, Warning Letters Reported by CBER, 2007-2010 34
Figure 4: Drug Recalls and Warning Letters, Warning Letters Reported by CDRH, 2007-2010 38
Figure 5: Drug Recalls and Warning Letters, Warning Letters Reported by CFSAN, 2007-2010 39
Figure 6: Drug Recalls and Warning Letters, Warning Letters Reported by CVM, 2007-2010 40
Figure 7: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2007-2010 41
Figure 8: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2010 43
Figure 9:Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2009 44
Figure 10: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2008 45
Figure 11: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency by Reason, 2007 46
Figure 12: Drug Recalls and Warning Letters, Warning Letters Reported for Regulatory Errors, 2007-2010 47
Figure 13: Drug Recalls and Warning Letters, Warning Letters Reported for Clinical Research Errors, 2007-2010 48
Figure 14: Drug Recalls and Warning Letters, Warning Letters Reported for Marketing Errors, 2007-2010 49
Figure 15: Drug Recalls and Warning Letters, Warning Letters Reported for Manufacturing Errors, 2007-2010 50
Figure 16: Drug Recalls and Warning Letters, Warning Letters Reported for Quality Errors, 2009-2010 51
Figure 17: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency (%), 2007 52
Figure 18: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency (%), 2008 53
Figure 19: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency (%), 2009 54
Figure 20: Drug Recalls and Warning Letters, Warning Letters Reported by FDA Agency (%), 2010 55
Figure 21: Drug Recalls and Warning Letters, Total Number of Recall by All Agencies, 2007-2010 58
Figure 22: Drug Recalls and Warning Letters, Drug Recalls by CDER, 2007, 2008 and 2010 59
Figure 23: Drug Recalls and Warning Letters, Number of Drug Product Recalls by CDER by Class, 2007, 2008 and 2010 60
Figure 24: Drug Recalls and Warning Letters, Drug Recalls by CBER, 2007, 2008 and 2010 61
Figure 25: Drug Recalls and Warning Letters, Number of Biological Product Recalls by CBER by Class, 2007, 2008 and 2010 62
Figure 26: Drug Recalls and Warning Letters, Product Recalls by CDER, CBER and Other Agencies, 2007, 2008 and 2010 63
Figure 27: Drug Recalls and Warning Letters, Total Number of Drug Recalls, 2007-2010 64
Figure 28: Drug Recalls and Warning Letters, Number of Drug Recalls by Reason for Recall, 2007-2010 76
Figure 29: Drug Recalls and Warning Letters, Drug Recalls by Product Class, 2007-2010 77
Figure 30: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form, 2007-2010 78
Figure 31: Drug Recalls and Warning Letters, Drug Recalls by Companies, 2007-2010 79
Figure 32: Drug Recalls and Warning Letters, Drug Recalls by Drug Class, 2007-2010 81
Figure 33: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area, 2007-2010 83
Figure 34: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area (%), 2007 85
Figure 35: Drug Recalls and Warning Letters, Drug Recalls by Drug Class (%), 2007 86
Figure 36: Drug Recalls and Warning Letters, Drug Recalls by Product Class (%), 2007 87
Figure 37: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form (%), 2007 88
Figure 38: Drug Recalls and Warning Letters, Drug Recalls by Companies (%), 2007 89
Figure 39: Drug Recalls and Warning Letters, Drug Recalls by Reason for Recall (%), 2007 90
Figure 40: Drug Recalls and Warning Letters, Drug Recalls due to Manufacturing Reasons (%), 2007 91
Figure 41: Drug Recalls and Warning Letters, Drug Recalls due to Quality Reasons (%), 2007 92
Figure 42: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area (%), 2008 93
Figure 43: Drug Recalls and Warning Letters, Drug Recalls by Drug Class (%), 2008 95
Figure 44: Drug Recalls and Warning Letters, Drug Recalls by Product Class (%), 2008 97
Figure 45: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form (%), 2008 98
Figure 46: Drug Recalls and Warning Letters, Drug Recalls by Companies (%), 2008 99
Figure 47: Drug Recalls and Warning Letters, Drug Recalls by Reason for Recall (%), 2008 101
Figure 48: Drug Recalls and Warning Letters, Drug Recalls due to Manufacturing Reasons (%), 2008 102
Figure 49: Drug Recalls and Warning Letters, Drug Recalls due to Quality Reasons (%), 2008 103
Figure 50: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area (%), 2009 104
Figure 51: Drug Recalls and Warning Letters, Drug Recalls by Drug Class (%), 2009 106
Figure 52: Drug Recalls and Warning Letters, Drug Recalls by Product Class (%), 2009 107
Figure 53: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form (%), 2009 108
Figure 54: Drug Recalls and Warning Letters, Drug Recalls by Companies (%), 2009 110
Figure 55: Drug Recalls and Warning Letters, Drug Recalls by Reason for Recall (%), 2009 111
Figure 56: Drug Recalls and Warning Letters, Drug Recalls due to Manufacturing Reasons (%), 2009 112
Figure 57:Drug Recalls and Warning Letters, Drug Recalls due to Quality Reasons (%), 2009 113
Figure 58: Drug Recalls and Warning Letters, Drug Recalls by Therapy Area (%), 2010 114
Figure 59: Drug Recalls and Warning Letters, Drug Recalls by Drug Class (%), 2010 116
Figure 60: Drug Recalls and Warning Letters, Drug Recalls by Product Class (%), 2010 118
Figure 61: Drug Recalls and Warning Letters, Drug Recalls by Dosage Form (%), 2010 119
Figure 62: Drug Recalls and Warning Letters, Drug Recalls by Companies (%), 2010 120
Figure 63: Drug Recalls and Warning Letters, Drug Recalls by Reason for Recall (%), 2010 121
Figure 64: Drug Recalls and Warning Letters, Drug Recalls due to Manufacturing Reasons (%), 2010 122
Figure 65: Drug Recalls and Warning Letters, Drug Recalls due to Quality Reasons (%), 2010 123
Figure 66: Drug Recalls and Warning Letters, Number of Drug Recalls due to Manufacturing Reasons, 2007-2010 124
Figure 67: Drug Recalls and Warning Letters, Number of Drug Recalls due to Quality Defects, 2007-2010 125

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