This FDA InspectorProfile is a report of relevant audit-related information on Luis Dasta, 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 Luis Dasta's inspections in 15 countries: China, United States, Canada, Italy, Spain, Japan, Germany, France, India, United Kingdom, Czech Republic, Korea (the Republic of), Hong Kong SAR, Switzerland, and Morocco.
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 Luis Dasta'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 Luis Dasta.
Note: The EIR and 483 documents are sold separately.