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Simone E Pitts

Data since January 01, 2022

Active

View Detailed Investigator Profile

Investigation Details

Last Issued Date

September 30, 2024

Form 483s Issued

3

Warning Letters Issued (since 2022)

0

Conversion Rate (483 to Warning Letter)

0

%

Countries Inspected

USA

FDA Investigators having one site common

Ucheabuchi C Chudi-Nwankwor , Scott Golladay , Jazmine N Still , Lauren H Augustyniak , Jazmine N Brown

483s Issues in Countries

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

Environmental Monitoring

4

Process Control

4

Contamination Control

2

Process Validation

2

Facility Design

2

Unblock Complete Sub-Systems Insights

Top 5 Co-Investigators

Co-Investigator

Joint Inspections

Details

Scott Golladay

2

-

Jazmine N Still

2

Ucheabuchi C Chudi-Nwankwor

1

Lauren H Augustyniak

1

Jazmine N Brown

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

Environmental Monitoring

4

Process Control

4

Contamination Control

2

Process Validation

2

Facility Design

2

Top 5 Co-Investigators

Co-Investigator

Joint Inspections

Details

Scott Golladay

2

-

Jazmine N Still

2

Ucheabuchi C Chudi-Nwankwor

1

Lauren H Augustyniak

1

Jazmine N Brown

1

Investigator Analysis

Profile

FDA investigator Simone E Pitts demonstrates a strong inclination towards contamination control, scrutinizing manufacturing processes and quality control procedures. He exhibits meticulous attention to detail and follows a methodical approach deeply rooted in ensuring adequate testing, proper disinfectant dispensing, temperature control and sterilization. With a history of focusing on system qualifications, aseptic process validation, and proper procedure adherence, he has a reputation for placing a high premium on effective and comprehensive risk assessment and proper documentation.

Approach

Simone E Pitts tends to approach inspections in a systematic and detailed manner, focusing on adherence to procedures, effective quality control, rigorous risk assessment, and contamination control. Emphasizing on solid aseptic field integrity and the importance of SOP compliance to ensure product safety and effectiveness.

Form 483s Issued

Issue Date

Facility Name

Product Type

Form 483

Converted

Warning Letter

30 Sep 2024

Pine Pharmaceuticals, LLC

Drugs

17 Jan 2020

Hospira Inc

Drugs

17 Jan 2020

Hospira Inc

Drugs

18 Dec 2006

Nice Pak Products, Inc.

Drugs

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FDA Investigator Profile

Simone E Pitts

Active

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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