This InspectorProfile is a report of relevant audit-related information on Helen Ricalde, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.
This InspectorProfile report is updated through and lists Helen Ricalde's 219 inspections in 22 countries: United States, France, Germany, Italy, Spain, Belgium, Korea (the Republic of), Denmark, United Kingdom, Sweden, Austria, Ireland, Australia, Switzerland, Singapore, Mexico, Peru, Malta, India, Canada, Norway, and Netherlands.
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 Helen Ricalde'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 Helen Ricalde.
Note: The EIR and 483 documents are sold separately.Add To Cart22 of Helen's 483s Available Now.