FDA Deficiency Database Dashboard
Total FDA Deficiency Database
5797
Total Dosage Forms - 9
Total Dosage Types - 22
Total Deficiency Types
27
Total Category of Deficiency
(DRL,Major CR,Minor CR)
3
Total CMC Sections
(Drug Product,Drug Substance)
2
Category of Deficiency vs Deficiency Count
Deficiency by CMC Section
Deficiency count based on Total Deficiency Types
32P - Specification & CoA
912
32P - Manufacturing Process/Scale-up
623
32P - Method & Validation
583
32P - In-Process Controls
456
32P - Product Development Report
455
32P - Stability
389
32S - Method & Validation
300
32S - Specification & CoA
287
32P - Microbiology
282
32P - Container/Closure
280
M5 - BE & In-Vitro Dissolution
256
32P - Characterization & Justification
211
32R - ANDA Exhibit Batch/Reconciliation
111
32S - General Property/Administrative
109
32P - Excipients
108
32S - Characterization & Justification
94
32P - Components & Composition
81
Administrative & Facilities
71
32R - Drug-Device
62
32S - Reference Standard
37
32P - Reference Standard
31
32S - Stability
24
32P - Batch Formula
17
32S - Container/Closure
10
32S - Critical Steps and Intermediates
4
32R - NDA Exhibit Batch/Reconciliation
3
32P - Process Validation
1