This InspectorProfile is a report of relevant audit-related information on Edward Janik, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Medical Devices & Rad Health.
This InspectorProfile report is updated through and lists Edward Janik's 353 inspections in 15 countries: United States, Canada, Germany, Spain, Korea (the Republic of), Japan, Switzerland, Italy, India, United Kingdom, Russia, Israel, Ireland, Malaysia, 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 Edward Janik'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 Edward Janik.
Note: The EIR and 483 documents are sold separately.Add To Cart17 of Edward's 483s Available Now.