FDA Deficiency Database Dashboard
Total FDA Deficiency Database
5219
Total Dosage Forms - 9
Total Dosage Types - 21
Total Deficiency Types
28
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
869
32P - Manufacturing Process/Scale-up
540
32P - Method & Validation
524
32P - Product Development Report
424
32P - In-Process Controls
418
32P - Stability
359
32S - Method & Validation
285
32S - Specification & CoA
271
32P - Microbiology
253
32P - Container/Closure
244
M5 - BE & In-Vitro Dissolution
214
32P - Characterization & Justification
167
32R - ANDA Exhibit Batch/Reconciliation
101
32P - Excipients
99
32S - Characterization/Justification
66
32S - General/Administrative
65
Administrative & Facilities
61
32S - General Property/Administrative
42
32P - Components/Composition
42
32S - Reference Standard
36
32P - Components & Composition
30
32P - Reference Standard
25
32S - Stability
23
32S - Characterization & Justification
22
32R - Drug-Device
18
32P - Batch Formula
11
32S - Container/Closure
9
32P - Process Validation
1