FDA Inspection Readiness Checklist Form
Evaluate your facility’s preparedness for an FDA inspection using this focused checklist.
Date of Assessment
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Facility Name
*
Are all required SOPs current and easily accessible?
*
Yes
No
Partial
Which of the following areas have been reviewed in the last 30 days?
*
Documentation
Training Records
Facility Cleanliness
Labeling Compliance
Equipment Calibration
Other
Rate overall staff training readiness for inspection.
*
1
2
3
4
5
Is a recent internal audit report available?
*
Yes
No
Are corrective and preventive actions (CAPA) documented and up to date?
*
Yes
No
In Progress
List key documents prepared for the inspection.
Are there any open inspection findings from previous audits?
*
Yes
No
Additional comments or notes
Submit Assessment
Should be Empty: