This InspectorProfile is a report of relevant audit-related information on Don Bark, 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 Don Bark's 25 inspections in 11 countries: Canada, Germany, Italy, Finland, Netherlands, Spain, Denmark, Ireland, United States, United Kingdom, and Switzerland.
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 Don Bark'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 Don Bark.
Note: The EIR and 483 documents are sold separately.Add To Cart10 of Don's 483s Available Now.