How to Prepare for an FDA Inspection
Instructions
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Ensure that all employees are informed of the inspection or audit to have it run smoothly.
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Assign jobs to any employees under your management. Have one employee ready to receive the inspector when she arrives, have another person to check the inspector's credentials and have an employee give the inspector a tour of your facility.
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Require the employees you manage to completely memorize the correct policies and procedures your company has in place that relate to quality control.
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Brief any quality assurance employees at your company about what the inspector will ask them specifically.
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Gather items important to the inspection and have them ready to show the inspector. These items can include building diagrams, product samples and documentation of any clinical trials. An FDA inspector will check everything, regardless of what the focus of the inspection is.
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