Question
This week we have discussed FDA inspections. Given the following facts, please identify all relevant issues in the following inspection scenario including what the Company
This week we have discussed FDA inspections. Given the following facts, please identify all relevant issues in the following inspection scenario including what the Company can and cannot do and why:
The manufacturing plant operates 24 hours a day and 7 days a week
The FDA inspector comes to front door at 2 am
The FDA inspector wants to wander around plant
The FDA inspector wants to go inside all locked doors and open locked lockers
The FDA inspector wants to take pictures
The FDA inspector wants to interview any employee the inspector sees
The FDA inspector does not want anyone from Company to accompany him or her
Give me references also
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