This InspectorProfile is a report of relevant audit-related information on Karen Cooper, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.
This InspectorProfile report is updated through and lists Karen Cooper's 397 inspections in 18 countries: United States, Fiji, Peru, Brazil, Costa Rica, Canada, Romania, Switzerland, Netherlands, Denmark, Dominican Republic (the), Italy, Panama, South Africa, Czech Republic, Ecuador, United Kingdom, and Chile.
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 Karen Cooper'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 Karen Cooper.
Note: The EIR and 483 documents are sold separately.Add To Cart8 of Karen's 483s Available Now.