This InspectorProfile is a report of relevant audit-related information on Erika Butler, 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 Erika Butler's 211 inspections in 20 countries: United States, India, Italy, Austria, Slovenia, Israel, Germany, Switzerland, Belgium, South Africa, New Zealand, Ireland, Singapore, Spain, France, China, Thailand, Japan, Korea (the Republic of), and Canada.
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 Erika Butler'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 Erika Butler.
Note: The EIR and 483 documents are sold separately.Add To Cart35 of Erika's 483s Available Now.