John Mistler

Mistler's approach to inspection appears thorough and meticulous. He focuses on the little details that might cause significant issues if overlooked, particularly those that can compromise the sterility of the product and adherence to FDA guidelines. His reviews suggest a detailed-oriented inspector who ensures companies comply with the full scope of FDA regulations.

John Mistler is an FDA auditor with a keen focus on sterility testing, aseptic processing and the maintenance of equipment within a facility. He is meticulous and thorough, identifying both operational and technical non-compliance issues. His history of inspections suggests a preference for strict adherence to FDA's regulation and operational procedures, with a focus on preventing microbial contamination, inadequate sterility test procedures, and deficiencies in computer system controls. If there is a discrepency or unexplained failure, it is likely he will invest significant time into understanding the root cause.