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George Kastanis
Data since January 01, 2022
Active
Active
Moderately Active
Inactive
View Detailed Investigator Profile

Investigation Details

Last Issued Date
March 13, 2026
Form 483s Issued
0
Warning Letters Issued (since 2022)
0
Conversion Rate (483 to Warning Letter)
0
%

483s Issues in Countries

Countries
No of Investigation Done
United States of America
230
United Kingdom
120
India
72
United Arab Emirates
53
Australia
18

Form 483 Issued by Year

Form 483s
Observation Categories
Critical

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Major

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Minor

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Top 5 Sub-Systems

Subsystem
Occurrences
Detailed Analysis
Contamination Control
1
Analysis
Environmental Monitoring
1
Analysis
HVAC
1
Analysis
Material Receipt and Handling
1
Analysis
Equipment Qualification
1
Analysis
Rank
Sub-System Name
Detailed Sub-System Analysis
1
Environmental Monitoring
Analysis
2
Contamination Control
Analysis
3
Data Integrity
Analysis
4
Document Management
Analysis
5
Batch Records
Analysis
Unblock Complete Sub-Systems Insights

Top 5 Co-Investigators

Co-Investigator
Joint Inspections
Details
Zainab Mansaray-Storms, PhD
1
-
Evi Struble, PhD
1
-
Lu Deng, PhD
1
-
Nitin Verma
1
View Details
Hailing Yan, MS
1
-
Investigator Name
No of Investigation Done
Stephen D Brown
4
Margaret M Annes
3
June P Page
3
Justin A Boyd
6
Patty P Kaewussdangkul
1
Explore Full Investigator Network
Observation Categories
Critical

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Major

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Minor

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Top 5 Sub-Systems

Subsystem
Occurrences
Detailed Analysis
Contamination Control
1
Analysis
Environmental Monitoring
1
Analysis
HVAC
1
Analysis
Material Receipt and Handling
1
Analysis
Equipment Qualification
1
Analysis

Top 5 Co-Investigators

Co-Investigator
Joint Inspections
Details
Zainab Mansaray-Storms, PhD
1
-
Evi Struble, PhD
1
-
Lu Deng, PhD
1
-
Nitin Verma
1
View Details
Hailing Yan, MS
1
-

Investigator Analysis

Profile

George Kastanis is a detail-oriented FDA investigator who places a strong emphasis on GMP compliance and quality systems in drug substance and product manufacturing. He is particularly concerned about adherence to standard manufacturing protocols and the adequacy of quality control testing.

Approach

George Kastanis'' approach focuses on meticulously scrutinizing GMP compliance, quality systems, and manufacturing protocols. He prioritizes the identification of deficiencies and potential risks to product safety and efficacy during inspections.

Form 483s Issued

Issue Date
Facility Name
Product Type
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
Analysis
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
13 Mar 2026
Grifols Diagnostic Solutions
Drugs
View Form 483
About
Form 483’s
Facility Name
Product Type
483 Form
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Pharmacy Plus, Inc. dba Vital Care
Drugs
483 URL
Analysis
Warning Letter
Pharmacy Plus, Inc. dba Vital Care
Drugs
483 URL
Analysis
Warning Letter
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Pharmacy Plus, Inc. dba Vital Care
Drugs
483 URL
Analysis
Warning Letter
Pharmacy Plus, Inc. dba Vital Care
Drugs
483 URL
Analysis
Warning Letter

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FDA Investigator Profile

George Kastanis

Active
Active
Moderately Active
Inactive
Data since January 01, 2022
Get exclusive insights into FDA investigator behavior. Built for Pharma Quality Leaders.
✔️ 483s issued & warning letter rate

✔️ Top cited sub-systems

✔️ Facilities inspected & co-investigators

✔️ Inspection outcomes & trends
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What’s Inside the FDA Investigator Profile

Compliance Action Overview

A quick summary of the inspector’s regulatory track record—facilities inspected, total Form 483s issued, warning letters, and conversion rate. Also shows their last activity date, countries inspected, and investigators they've worked with.
Leucine Elogbook software digitizing paper forms with automated data capture
Linked stations via Leucine logbook ensuring consistent shopfloor processes

Inspection Trend

A year-by-year graph showing the number of Form 483s issued by this investigator. Spot patterns of enforcement activity, consistency, and recent engagement.

Focus Areas: Top Sub-Systems

Top 5 areas the investigator commonly cites in inspections. Understand where they focus their scrutiny and prepare for similar risk areas.
Flowchart showing SOP compliance via interlocks with ALCOA & GMP focus
Operator scans QR code to input data into Leucine’s e log book accurately

Co-Investigator Network

Names and frequency of other FDA investigators who have jointly conducted inspections with this profile. Useful for identifying recurring teams and collaborative inspection patterns.

Facility-Level Inspection History

Detailed list of facilities inspected—company names, locations, and inspection dates. Offers a view of where the investigator has been active and which companies were under their scope.
Audit trail showing timestamps and flags for regulatory compliance
Operator scans QR code to input data into Leucine’s e log book accurately

Inspection Outcomes

Facility-wise breakdown of Form 483s and whether they escalated to warning letters. Also includes the product type involved and inspection issue dates—crucial for understanding enforcement severity.
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