This FDA InspectorProfile is a report of relevant audit-related information on Gale Glinecki, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Foods & Cosmetics.
This InspectorProfile report is updated through and lists Gale Glinecki's inspections in 39 countries: Norway, United States, Thailand, Poland, Estonia, United Kingdom, Peru, India, Spain, China, Brazil, Belgium, Bangladesh, Guatemala, Panama, Argentina, Mexico, Chile, Japan, Italy, Serbia, Korea (the Republic of), Taiwan, Taiwan (Province of China), Ecuador, Sri Lanka, Malaysia, Nicaragua, Portugal, Vietnam, Philippines, Slovakia, South Africa, Guyana, France, Indonesia, Germany, Latvia, and Lithuania.
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 Gale Glinecki'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 Gale Glinecki.
Note: The EIR and 483 documents are sold separately.