Nicole Knowlton InspectorProfile

$995.00

This InspectorProfile is a report of relevant audit-related information on Nicole Knowlton, 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 May 21 2020 and lists Nicole Knowlton's 191 inspections in 19 countries: United States, France, Switzerland, Germany, China, India, Italy, Spain, United Kingdom, Korea (the Republic of), Bulgaria, Ireland, Netherlands, Taiwan (Province of China), Malaysia, Singapore, Malta, Greece, and Israel.

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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 Nicole Knowlton'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 Nicole Knowlton.

Example Report

Nicole Knowlton FDA InspectorProfile Overview Example

Nicole Knowlton FDA InspectorProfile Metrics Example

Nicole Knowlton FDA InspectorProfile Citations Example

Nicole Knowlton FDA InspectorProfile Inspections List

Add To Cart 49 of Knowlton 483s in stock

Product details

Nicole Knowlton'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) Nicole Knowlton has conducted including:
- Company, site inspected, duration of inspection
- Co-inspectors like Ruo Xu FDA, Kejun Cheng FDA, Marcellinus Dordunoo FDA, Rozelle Smith FDA, Steven Donald 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 49 of Nicole's 483s Available Now.