Experience Leucine AI.
Powered Pharma Operations

Transform Your Pharma Operations with AI-Powered Intelligence. Experience how Leucine's integrated platform brings together manufacturing, quality, and laboratory operations in one digital ecosystem. Schedule a personalized demo to see how our AI solutions can optimize your processes, ensure compliance, and drive operational excellence.

See How AI Transforms Your Shop Floor Operations.
Experience firsthand how Leucine's 10x MES digitalizes batch records, streamlines production, and provides real-time monitoring of your manufacturing operations. Schedule a personalized demo to discover how our AI-powered platform can enhance your productivity while maintaining compliance.

Experience AI-Driven Quality Management in Action.
See how Leucine's 10x QMS automates compliance workflows, streamlines change control, and ensures regulatory adherence. Schedule a demo to learn how our AI-powered platform can help you manage quality processes more efficiently while reducing compliance risks.

Discover Smart Laboratory Operations Management.
Watch how Leucine's 10x LES orchestrates your lab operations, automates documentation, and ensures data integrity. Schedule a demo to see how our AI-powered platform can accelerate your testing processes while maintaining audit-readiness.

Optimize your manufacturing processes with paperless operations
Strengthen quality management and regulatory compliance
Accelerate laboratory operations and testing workflows

Connect with a Leucine Expert

Schedule a 30-Minute Product Demo with Expert Q&A

Patty P Kaewussdangkul
Data since January 01, 2022
Moderately Active
Active
Moderately Active
Inactive
View Detailed Investigator Profile

Investigation Details

Last Issued Date
January 30, 2023
Form 483s Issued
27
Warning Letters Issued (since 2022)
4
Conversion Rate (483 to Warning Letter)
0
%
Investigator ID
13209281
Countries Inspected
Malaysia, USA
FDA Investigators having one site common

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
7
Laboratory Controls
5
Cleaning Validation
4
Batch Records
4
Process Control
4
Unblock Complete Sub-Systems Insights

Top 5 Co-Investigators

Co-Investigator
Joint Inspections
Details
Margaret M Annes
4
Lori G Cantin
2
Steven A Brettler
2
Bonita S Chester
2
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
7
Laboratory Controls
5
Cleaning Validation
4
Batch Records
4
Process Control
4

Top 5 Co-Investigators

Co-Investigator
Joint Inspections
Details
Margaret M Annes
4
Lori G Cantin
2
Steven A Brettler
2
Bonita S Chester
2

Investigator Analysis

Profile

Patty P Kaewussdangkul is a detail-oriented FDA auditor with a strong focus on sterile product manufacturing processes, batch review procedures, corrective actions in aseptic areas, test method validation, and employee training.

Approach

Patty P Kaewussdangkul prioritizes scrutinizing sterile product manufacturing processes, batch review procedures, corrective actions and validations in aseptic areas, and employee training. They are keen on thorough documentation and adherence to established procedures.

Form 483s Issued

Issue Date
Facility Name
Product Type
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
30 Jan 2023
Bond Pharmacy dba Advanced Infusion Solutions
Drugs
09 Dec 2022
Purformance Wellness Pharmacy LLC dba Seven Cells
Drugs
30 Sep 2022
Qualgen, LLC
Drugs
14 Jun 2022
FARMAKEIO OUTSOURCING LLC
Drugs
10 Mar 2022
North American Custom Laboratories, LLC
Drugs
18 Feb 2022
Davis City Pharmacy Inc.
Drugs
03 Nov 2021
Bhaumik Diversified LLC dba Texas Star Pharmacy
Drugs
24 Sep 2021
Pharmcore Inc. dba Hallandale Pharmacy
Drugs
27 May 2021
Innoveix Pharmaceuticals Inc
Drugs
26 Feb 2020
Solaris Pharmacy, Inc.
Drugs
12 Nov 2019
Right Value Drug Stores, LLC dba Carie
Drugs
01 Jul 2019
Dougherty's Pharmacy
Drugs
11 Jun 2018
Stonegate Pharmacy LP
Drugs
23 Apr 2018
Guardian Pharmacy Services
Drugs
20 Apr 2018
Guardian Pharmacy Services
Drugs
14 Jun 2017
Absolute Veterinary Compounding Pharmacy
Drugs
12 May 2017
Right Value Drug Stores, Inc.
Drugs
13 Jan 2017
MOORE'S COMPOUNDING PHARMACY
Drugs
13 Jan 2017
MOORE'S COMPOUNDING PHARMACY
Drugs
29 Jun 2016
Talon Compounding Pharmacy
Drugs
02 Mar 2016
Stonegate Pharmacy LP
Drugs
02 Mar 2016
Stonegate Pharmacy LP
Drugs
06 Mar 2015
D.R. Pharmacy, Inc.
Drugs
28 Jul 2014
Peoples Pharmacy, Inc. #2
Drugs
17 Jun 2013
Eagle Analytical Services
Drugs
05 Jul 2006
Haifa Smoked Fish, Inc.
Drugs
Facility Name
Product Type
483 Form
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs

Unlock Insights from 483s & Stay Audit Ready with FDA Tracker

Monitor FDA Six Systems, Analyse 483s with Observations, Investigators & Companies

Get Started Now

Get FDA Alerts on WhatsApp

Instant updates on FDA Form 483s and Warning Letters.
Join Now for real-time alerts!
Click Here or Scan QR to Join
Go Back
FDA Investigator Profile

Patty P Kaewussdangkul

Moderately 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
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Your PDF is currently downloading. Please wait for the process to complete.

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.
View and learn more about Cleaning Validation with our comprehensive list of resources
Analyze FDA Compliance Gaps, Stay Audit Ready with AI
Analyze FDA 483s and Warning Letters, uncover trends, get real-time alerts, and access investigator profiles to simplify audit prep.