Complete Response Database
Total Complete Response Deficiencies Database
1231
Total Dosage Forms
9
Total Deficiency Types
28
Total Dosage Types
20
Total CMC Sections
(Drug Product,Drug Substance)
2
Dosage Form types by Deficiency Count
Deficiency by CMC Section
Deficiency count based on Total Deficiency Types
32P - Specification & CoA
143
32P - Method & Validation
130
32P - Manufacturing Process/Scale-up
115
32P - Product Development Report
104
32P - In-Process Controls
97
32P - Container/Closure
90
32P - Stability
76
32P - Characterization & Justification
70
M5 - BE & In-Vitro Dissolution
69
32S - Method & Validation
50
32R - Drug-Device
48
32S - Specification & CoA
44
32P - Microbiology
39
32R - ANDA Exhibit Batch/Reconciliation
29
32P - Excipients
22
Administrative & Facilities
20
32S - Characterization & Justification
16
32P - Components & Composition
12
32S - General/Administrative
10
32S - Characterization/Justification
9
32S - Reference Standard
8
32S - General Property/Administrative
7
32P - Reference Standard
7
32S - Container/Closure
4
32S - Critical Steps and Intermediates
4
32S - Stability
3
32R - NDA Exhibit Batch/Reconciliation
3
32P - Batch Formula
2