This FDA InspectorProfile is a report of relevant audit-related information on Michele Obert, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Human Drugs.
This InspectorProfile report is updated through and lists Michele Obert's inspections in 25 countries: United States, New Zealand, India, Japan, China, Ireland, Malta, United Kingdom, Italy, Germany, Denmark, Belgium, Iceland, Australia, Singapore, France, Netherlands, Sweden, South Africa, Slovenia, Spain, Switzerland, Poland, Bulgaria, and Austria.
FDA audits are stressful. Whether you are issued a 483 depends largely on your compliance with GxP and predicate rules; but it can also depend on the Agency's current focus and the tendencies of your specific investigator(s). FDAzilla has curated Michele Obert's inspection information so that you can mitigate investigator-related risks.
Below is an example of what a FDAzilla InspectorProfile report contains; This is not the actual data for Michele Obert.
Note: The EIR and 483 documents are sold separately.