This InspectorProfile is a report of relevant audit-related information on Marcelo Mangalindan, 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 Marcelo Mangalindan's 195 inspections in 18 countries: United States, Argentina, Hungary, Canada, Belgium, Poland, France, South Africa, Slovakia, Italy, United Kingdom, Australia, Germany, Korea (the Republic of), Spain, Korea, Republic Of (South), Netherlands, and Taiwan.
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 Marcelo Mangalindan'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 Marcelo Mangalindan.
Note: The EIR and 483 documents are sold separately.Add To Cart27 of Marcelo's 483s Available Now.