This InspectorProfile is a report of relevant audit-related information on Nicole Knowlton, 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 Nicole Knowlton's 185 inspections in 18 countries: United States, France, Switzerland, Germany, China, India, Italy, Spain, United Kingdom, Korea (the Republic of), Bulgaria, Ireland, Netherlands, Taiwan (Province of China), Malaysia, Singapore, Greece, and Malta.
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 Nicole Knowlton'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 Nicole Knowlton.
Note: The EIR and 483 documents are sold separately.Add To Cart46 of Nicole's 483s Available Now.