This FDA InspectorProfile is a report of relevant audit-related information on Donald Lech, 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 Donald Lech's inspections in 11 countries: United States, Austria, Germany, France, Czech Republic, China, United Kingdom, Taiwan, Spain, Italy, and Canada.
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 Donald Lech'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 Donald Lech.
Note: The EIR and 483 documents are sold separately.