Gene Arcy InspectorProfile

$795.00

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

Product Description

This InspectorProfile report is updated through Jul 24 2020 and lists Gene Arcy's 329 inspections in 9 countries: United States, India, Belgium, United Kingdom, Switzerland, Germany, Canada, Spain, and Australia.

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 Gene Arcy'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 Gene Arcy.

Example Report

Gene Arcy FDA InspectorProfile Overview Example

Gene Arcy FDA InspectorProfile Metrics Example

Gene Arcy FDA InspectorProfile Citations Example

Gene Arcy FDA InspectorProfile Inspections List

Add To Cart 45 of Arcy 483s in stock

Product details

Gene Arcy'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) Gene Arcy has conducted including:
- Company, site inspected, duration of inspection
- Co-inspectors like James Kenney FDA, Hyesuk Kong FDA, Dino Feigelstock FDA, Nancy Neiger FDA, Simone Pitts 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 45 of Gene's 483s Available Now.