John Iwen InspectorProfile

$795.00

This InspectorProfile is a report of relevant audit-related information on John Iwen, a U.S. Food & Drug Administration investigator who primarily conducts inspections in the area of Biologics.

Product Description

This InspectorProfile report is updated through Aug 19 2020 and lists John Iwen's 607 inspections in 5 countries: United States, India, Canada, Norway, and Belgium.

Add InspectorProfile + Last 5 x 483 - $995

Add InspectorProfile - $795

Add Last 5 x 483 - $595

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 John Iwen'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 John Iwen.

Example Report

John Iwen FDA InspectorProfile Overview Example

John Iwen FDA InspectorProfile Metrics Example

John Iwen FDA InspectorProfile Citations Example

John Iwen FDA InspectorProfile Inspections List

Add To Cart 11 of Iwen 483s in stock

Product details

John Iwen's metrics:
- 483 issue rate, total inspections, total 483s
- Most common citations (based on CFR), CFR description, and citation frequency
- Total inspections, total 483s
- Longest / shortest inspection in duration - all time, last year
- Total warning letters
Inspection details for each inspection (since 2000) John Iwen has conducted including:
- Company, site inspected, duration of inspection
- Co-inspectors like Eric Huebler FDA, Dawn Olenjack FDA, Brandi Williams FDA, Karen Montgomery FDA, Scott Jepson FDA, year of last co-inspection, number of co-inspections
- If a 483 issued, and whether or not it resulted in a warning letter.

Note: The EIR and 483 documents are sold separately.

Add To Cart 11 of John's 483s Available Now.