Johann Fitch InspectorProfile

$995.00

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

Product Description

This InspectorProfile report is updated through Aug 19 2020 and lists Johann Fitch's 297 inspections in 11 countries: United States, Sweden, Canada, Argentina, Romania, Netherlands, Italy, Ukraine, Czech Republic, Bosnia-Hercegovina, and Spain.

Add InspectorProfile + Last 5 x 483 - $1,195

Add InspectorProfile - $995

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 Johann Fitch'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 Johann Fitch.

Example Report

Johann Fitch FDA InspectorProfile Overview Example

Johann Fitch FDA InspectorProfile Metrics Example

Johann Fitch FDA InspectorProfile Citations Example

Johann Fitch FDA InspectorProfile Inspections List

Add To Cart 16 of Fitch 483s in stock

Product details

Johann Fitch'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) Johann Fitch has conducted including:
- Company, site inspected, duration of inspection
- Co-inspectors like Zhou Chen FDA, Mark Seaton FDA, Eias Zahalka FDA, Diane Van Leeuwen FDA, Robert Lorenz 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 16 of Johann's 483s Available Now.