SOCRA 2024 Annual Conference Program Book - Flipbook - Page 50
OBMI
• Name
• Number of divisions
• PDD and DIB role combined
Reorganization
Changes
Inspection
Process
Other inspectorates
• Compliance consolidated in
centers
• Recalls, complaint handling
13
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14
Inspection References
•
•
Center
Review
Division
Investigations Operations Manual
(IOM)
•
https://www.fda.gov/ICECI/Inspections/I
OM/default.htm
•
Chapter 5: Establishment Inspections
Compliance Programs (CPs)
•
•
Inspection Workflow
https://www.fda.gov/ICECI/Compliance
Manuals/ComplianceProgramManual/u
cm255614.htm
Center
BIMO
Staff
Regulations
•
•
•
21 CFR part 11, 50, 54, 56
Inspection
Assignment
Domestic
or Int’l
Division
21 CFR part 312, subpart D
21 CFR part 812, subpart C, subpart D,
subpart E, subpart G
15
www.fda.gov
16
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Inspection Flow
Inspection Workflow
Center
Review
Division
Opening
meeting
Walk
through
Data
review
Daily
interviews
Closing
meeting
Regulatory
Correspondence/
Follow-up
Center
BIMO
Staff
Inspection
Assignment
Domestic
or
Foreign
Division
EIR
www.fda.gov
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