483s Available - Drugs GMP
39
483 Completeness % - Drugs GMP
86.7%

Summary - Primary Issues Cited by Quality Area

Total Obs
304
Number of Observations by Primary Issues
Primary Issue L1:
Quality System
Production
Laboratory
Facilities and Equipment
Data Integrity
Materials
Packaging and Labeling
Created with Highcharts 9.3.084757161751
Primary Issues Over Time
Primary Issue L1:
Data Integrity
Facilities and Equipment
Laboratory
Materials
Packaging and Labeling
Production
Quality System
Created with Highcharts 9.3.06.1%1.8%3%1.1%2%12.1%14%16.7%16.7%27.6%24.5%24.2%21.1%33.3%31.8%20.7%16.3%1.8%1.5%2.3%2%1.8%27.3%29.8%16.7%15.2%23%34.7%30.3%29.8%33.3%31.8%25.3%20.4%201820192021202220232024

Primary Issues - Quality System (Quality Unit)

# of Obs
84
Number of Observations by Primary Issues (L2) - Quality System (Quality Unit)
Primary Issue L2:
Quality Unit Inadequate
Deviations / Investigations
Records and Reports
Complaint Management
Agency Notification
Change Control
Qualified Personnel
Created with Highcharts 9.3.03330105222
Primary Issues (L2) Over Time - Quality System (Quality Unit)
Primary Issue L2:
Agency Notification
Change Control
Complaint Management
Deviations / Investigations
Qualified Personnel
Quality Unit Inadequate
Records and Reports
Created with Highcharts 9.3.010%5.9%4.8%10%5.9%25%4.8%9.1%30%35.3%50%33.3%36.4%40%5.9%10%40%17.6%25%47.6%50%40%20%29.4%9.5%4.5%201820192021202220232024
Created with Highcharts 9.3.0Top Primary Issue Full Topics# of Obs3012885322222221111Quality System > Deviations / InvestigationsQuality System > Quality Unit Inadequate > Responsibilities and Authority > Procedures Not FollowedQuality System > Quality Unit Inadequate > Responsibilities and …Quality System > Quality Unit Inadequate > Quality System OversightQuality System > Quality Unit Inadequate > Quality System Over…Quality System > Quality Unit Inadequate > Quality Unit MissingQuality System > Complaint ManagementQuality System > Records and Reports > ProceduresQuality System > Change Control > GeneralQuality System > Qualified Personnel > PersonnelQuality System > Quality Unit Inadequate > Responsibilities and Authority > GeneralQuality System > Quality Unit Inadequate > Responsibilities and …Quality System > Quality Unit Inadequate > Reviews and ApprovalsQuality System > Quality Unit Inadequate > Reviews and Approv…Quality System > Records and Reports > Annual Product Quality ReviewQuality System > Records and Reports > Annual Product Quality…Quality System > Records and Reports > Batch ReleaseQuality System > Records and Reports > General > Document ControlQuality System > Records and Reports > General > Document C…Quality System > Agency Notification > BPDRQuality System > Agency Notification > Field AlertQuality System > Quality Unit Inadequate > GeneralQuality System > Records and Reports > General > Review and ApprovalQuality System > Records and Reports > General > Review and A…

Primary Issues - Production

# of Obs
75
Number of Observations by Primary Issues (L2) - Production
Primary Issue L2:
Sterile Products
Batch Records
Records and Reports
Contamination Control Lack of or Inadequate
Nonsterile Products
Process Monitoring
Process Validation Inadequate Or Missing
Cleaning Validation Or Verification
Personnel Responsibilities
Process Control
Retain Samples
Created with Highcharts 9.3.034111044332211
Primary Issues (L2) Over Time - Production
Primary Issue L2:
Batch Records
Cleaning Validation Or Verification
Contamination Control Lack of or Inadequate
Nonsterile Products
Personnel Responsibilities
Process Control
Process Monitoring
Process Validation Inadequate Or Missing
Records and Reports
Retain Samples
Sterile Products
Created with Highcharts 9.3.011.8%10%25%17.6%11.8%11.8%5%5.9%11.1%20%5.9%11.1%5.9%5.9%11.8%5.9%11.1%5.9%50%11.1%29.4%20%10%11.1%44.4%11.8%50%50%60%58.8%201820192021202220232024
Created with Highcharts 9.3.0Top Primary Issue Full Topics# of Obs2911105443321111Production > Sterile Products > Microbiological Contamination > GeneralProduction > Sterile Products > Microbiological Contamination >…Production > Batch RecordsProduction > Records and ReportsProduction > Sterile Products > Environmental Monitoring > GeneralProduction > Sterile Products > Environmental Monitoring > Ge…Production > Contamination Control Lack of or InadequateProduction > Nonsterile Products > Cross ContaminationProduction > Process Monitoring > Continued Process VerificationProduction > Process Validation Inadequate Or Missing > SterileProduction > Cleaning Validation Or Verification > ProceduresProduction > Personnel ResponsibilitiesProduction > Personnel Responsibilities > Limited Access Areas and EquipmentProduction > Personnel Responsibilities > Limited Access Areas …Production > Process Control > Time Limitations on ProductionProduction > Retain Samples

Primary Issues - Laboratory

# of Obs
71
Number of Observations by Primary Issues (L2) - Laboratory
Primary Issue L2:
System Controls
General Requirements
Stability
Method Validation
Records and Reports
OOS / OOT
Testing
Created with Highcharts 9.3.0272686211
Number of Observations by Primary Issues (L2) - Laboratory
Primary Issue L2:
General Requirements
Method Validation
OOS / OOT
Records and Reports
Stability
System Controls
Testing
Created with Highcharts 9.3.025%50%25%28.6%44.4%37.5%25%19%5.6%4.8%25%12.5%8.3%25%14.3%5.6%12.5%37.5%33.3%25%33.3%44.4%50%8.3%201820192021202220232024
Created with Highcharts 9.3.0Top Primary Issue Full Topics# of Obs271786622111Laboratory > System ControlsLaboratory > General Requirements > Laboratory Controls > GeneralLaboratory > General Requirements > Laboratory Controls > Ge…Laboratory > Stability > Stability ProgramLaboratory > General Requirements > Laboratory Controls > Test ProceduresLaboratory > General Requirements > Laboratory Controls > Tes…Laboratory > Method ValidationLaboratory > General Requirements > Laboratory Controls > Scientifically SoundLaboratory > General Requirements > Laboratory Controls > Sci…Laboratory > Records and ReportsLaboratory > General Requirements > Laboratory Controls > SpecificationsLaboratory > General Requirements > Laboratory Controls > Sp…Laboratory > OOS / OOTLaboratory > Testing > Routine Testing > General

Primary Issues - Facilities and Equipment

# of Obs
61
Number of Observations by Primary Issues (L2) - Facilities and Equipment
Primary Issue L2:
Design
Maintenance
Cleaning
Records and Reports
HVAC
Created with Highcharts 9.3.03511852
Primary Issues (L2) Over Time - Facilities and Equipment
Primary Issue L2:
Cleaning
Design
HVAC
Maintenance
Records and Reports
Created with Highcharts 9.3.012.5%50%9.1%16.7%8.3%75%50%50%63.6%45.8%75%12.5%4.2%25%18.2%25%8.3%25%9.1%8.3%8.3%201820192021202220232024
Created with Highcharts 9.3.0Top Primary Issue Full Topics# of Obs20117553322111Facilities and Equipment > Design > Sterile > GeneralFacilities and Equipment > Design > EquipmentFacilities and Equipment > Cleaning > Equipment > GeneralFacilities and Equipment > Maintenance > Equipment > Written ProgramFacilities and Equipment > Maintenance > Equipment > Written …Facilities and Equipment > Records and ReportsFacilities and Equipment > Maintenance > Equipment > GeneralFacilities and Equipment > Maintenance > FacilitiesFacilities and Equipment > Design > Facilities > GeneralFacilities and Equipment > HVACFacilities and Equipment > Cleaning > FacilitiesFacilities and Equipment > Design > PlumbingFacilities and Equipment > Design > Sterile > Cleanable

Primary Issues - Materials

# of Obs
5
Number of Observations by Primary Issues (L2) - Materials
Primary Issue L2:
Material Receipt and Handling
Material Sampling and Testing
Created with Highcharts 9.3.041
Primary Issues (L2) Over Time - Materials
Primary Issue L2:
Material Receipt and Handling
Material Sampling and Testing
Created with Highcharts 9.3.0100%100%50%100%50%2019202220232024
Created with Highcharts 9.3.0Top Primary Issue Full Topics# of Obs311Materials > Material Receipt and Handling > GeneralMaterials > Material Receipt and Handling > Use of Approved​Components and ContainersMaterials > Material Sampling and Testing > Identity Testing >​General

Primary Issues - Data Integrity

# of Obs
7
Number of Observations by Primary Issues (L2) - Data Integrity
Primary Issue L2:
Attributable
System Controls
Accurate
Backup and Archival
Contemporaneous
Created with Highcharts 9.3.022111
Primary Issues (L2) Over Time - Data Integrity
Primary Issue L2:
Accurate
Attributable
Backup and Archival
Contemporaneous
System Controls
Created with Highcharts 9.3.050%50%100%100%50%50%100%20182019202220232024
Created with Highcharts 9.3.0Top Primary Issue Full Topics# of Obs22111Data Integrity > Attributable > Lab RecordsData Integrity > System ControlsData Integrity > AccurateData Integrity > Backup and ArchivalData Integrity > Contemporaneous

Primary Issues - Packaging and Labeling

# of 483s
1
Number of Observations by Primary Issues (L2) - Packaging and Labeling
Primary Issue L2:
Label and Packaging Controls
Created with Highcharts 9.3.01
Primary Issues (L2) Over Time - Packaging and Labeling
Primary Issue L2:
Label and Packaging Controls
Created with Highcharts 9.3.0100%2019
Created with Highcharts 9.3.0Top Primary Issue Full Topics# of Obs1Packaging and Labeling > Label and Packaging Controls > General
Created with Highcharts 9.3.0