This FDA InspectorProfile is a report of relevant audit-related information on Jose Melendez, 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 Jose Melendez's inspections in 31 countries: United States, Mexico, Argentina, Italy, South Africa, Canada, United Kingdom, Ireland, Germany, Denmark, China, Brazil, Japan, Thailand, Belgium, Portugal, Spain, Czech Republic, Finland, India, Romania, New Zealand, Australia, Malta, Trinidad & Tobago, Dominican Republic (the), France, Hong Kong SAR, Malaysia, Singapore, and Korea (the Republic of).
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 Jose Melendez'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 Jose Melendez.
Note: The EIR and 483 documents are sold separately.