This FDA InspectorProfile is a report of relevant audit-related information on Charles Cote, 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 Charles Cote's inspections in 20 countries: United States, United Kingdom, Sweden, France, Portugal, Canada, South Africa, Czech Republic, Finland, Italy, Germany, Romania, New Zealand, Australia, Slovenia, Ireland, India, Norway, Belgium, and Spain.
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 Charles Cote'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 Charles Cote.
Note: The EIR and 483 documents are sold separately.