Complete Response Database
Total Complete Response Deficiencies Database
905
Total Dosage Forms
9
Total Deficiency Types
27
Total Dosage Types
19
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
122
32P - Method & Validation
97
32P - Manufacturing Process/Scale-up
86
32P - Product Development Report
84
32P - In-Process Controls
82
32P - Container/Closure
64
32P - Stability
55
M5 - BE & In-Vitro Dissolution
49
32S - Specification & CoA
42
32P - Characterization & Justification
42
32S - Method & Validation
42
32R - ANDA Exhibit Batch/Reconciliation
27
32S - Characterization/Justification
19
32P - Excipients
16
32P - Microbiology
16
Administrative & Facilities
13
32S - General/Administrative
11
32S - Reference Standard
7
32S - General Property/Administrative
6
32P - Components & Composition
5
32P - Components/Composition
5
32R - Drug-Device
4
32S - Characterization & Justification
3
32S - Container/Closure
3
32P - Reference Standard
2
32S - Stability
2
32P - Batch Formula
1