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"Real Stories of FDA Inspections" |
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| Help! This Page is in Danger of Disappearing from the IonSource web site unless we receive more inspection stories. Please consider making a contribution. Thank you. sincerely, Andrew Guzzetta. |
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Has the FDA Inspected Your Mass Spectrometry Laboratory or Core Facility? If so we think that everyone could benefit from your experience. Purpose: The purpose of this project is to promote the understanding of what a real inspection is like. For many of the uninitiated the thought of an FDA inspection is terrifying. Another purpose is to help relax those about to be inspected and to educate those that could benefit from our experience. Hopefully this will also serve to give us an up-to-date feeling for what inspectors are currently concentrating on. Introduction: We would like to hear about your experiences with the FDA, especially if the FDA has personally audited your mass spectrometry lab or core facility during or in connection with an FDA "Pre-Approval Inspection, PAI" or general facility reinspection. All entries are made through an anonymous submission form. Please do not include personal details, if you do (by mistake) they will be edited out of the contribution. There are three categories for submission; 1) Stories about inspections of your facility, 2) Stories you have heard about, 3) Tell us how you prepared for success. Please do not include any company names or inspector names. IonSource.Com will make no claim as to the validity of the story and does not accept liability for your lab preparedness. To prepare for interactions with the FDA, we suggest that you employ a qualified consultant in this field.
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