Rumany Penn InspectorProfile

$695.00

This InspectorProfile is a report of relevant audit-related information on Rumany Penn, 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 26 2019 and lists Rumany Penn's 64 inspections in 7 countries: United States, South Africa, France, India, Korea (the Republic of), Japan, and China.

Add InspectorProfile + Last 5 x 483 - $895

Add InspectorProfile - $695

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 Rumany Penn'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 Rumany Penn.

Example Report

Rumany Penn FDA InspectorProfile Overview Example

Rumany Penn FDA InspectorProfile Metrics Example

Rumany Penn FDA InspectorProfile Citations Example

Rumany Penn FDA InspectorProfile Inspections List

Add To Cart 19 of Penn 483s in stock

Product details

Rumany Penn'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) Rumany Penn has conducted including:
- Company, site inspected, duration of inspection
- Co-inspectors like James Lane FDA, Eileen Liu FDA, Christopher Reed FDA, Ashar Parikh FDA, Stephanie Slater 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 19 of Rumany's 483s Available Now.