Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST. Save Your Seat
Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST Save Your Seat
CLOSE
Back
Products
Resources
Visit Leucine's Experience Center
Discover our integrated AI-powered platform that helps you plan, execute, & optimize every batch
Schedule a Demo
Manufacturing Execution System
Quality Management System
Laboratory Execution System
FDA Insights
Resource Hub
Podcast and Event
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

Sub System /
System Controls
System Controls
View Detailed Analysis

Analytics Overview

5
Form 483s Issued
1
483s converted to WL
5
Total Observation
Form 483s Issued
+74 from last period

Analytics Overview

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter
01 Nov 2024
Janssen Biopharmaceuticals, Inc.
Drugs
View Form 483
22 Dec 2023
Eugia US Manufacturing LLC
Drugs
View Form 483
14 Dec 2023
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Carl Perez
1
0
Daniel L Zheng
1
0
James R Birkenstamm
1
0
Joan Cantellops
1
1
Bei Y. He
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Power outages affect environmental control as there were no failsafe measures documented or in place.
Excerpt: Your firm had a power outage... however, your firm has not determined the length of the outage, nor taken appropriate steps to mitigate the issue.
View Details
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: The observation highlights deficiencies in system controls, such as improper data formatting, inadequate backup procedures, and non-validated software usage, all of which directly impact data integrity and regulatory compliance.
Excerpt: The information presented is displayed in metadata format in a tabular layout, which does not assure that the data is readable and complete.
View Details
Control and maintenance of (b) (4) (b) (4) are deficient
Janssen Biopharmaceuticals, Inc.		 01 Nov 2024 Normal Justification: The observation highlights deficiencies in control and maintenance, directly pointing to issues within system controls.
Excerpt: Control and maintenance...deficient. Specifically, from 2022 to 2024, a total of 68 events occurred...
View Details
Input to and output from the computer and records or data are not checked for accuracy
Eugia US Manufacturing LLC		 22 Dec 2023 Normal Justification: The observation indicates that controls to manage data within the NetSCADA system are either inadequate or not properly implemented, affecting system reliability.
Excerpt: It is unclear how this data were acquired in this system and whether or not there are controls in place to avoid the addition or deletion of data.
View Details
Raw material management is inadequate
Suzhou Suncadia Biopharmaceuticals Co., Ltd.		 14 Dec 2023 Normal Justification: The ERP system failed to recognize and flag that China-only material was being used in a US-destined batch, indicating insufficient system control logic and configuration.
Excerpt: The GS ERP data management system is not designed to detect mix-ups of raw materials that are dedicated to either US or foreign markets.
View Details

Prepare Better for FDA Audits with FDA Tracker

Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
Stay Compliant: Manage risks proactively.
Sign Up Now
Go back

System Controls

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Written By
Vivek Gera
Reading Time
8
Minutes
Share

System Controls

Overview

5
Form 483s Issued
1
483s converted to WL
5
Total Observation
Form 483s Issued
+74 from last period

FDA Trends

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter
01 Nov 2024
Janssen Biopharmaceuticals, Inc.
Drugs
View Form 483
22 Dec 2023
Eugia US Manufacturing LLC
Drugs
View Form 483
14 Dec 2023
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Carl Perez
1
0
Daniel L Zheng
1
0
James R Birkenstamm
1
0
Joan Cantellops
1
1
Bei Y. He
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Power outages affect environmental control as there were no failsafe measures documented or in place.
Excerpt: Your firm had a power outage... however, your firm has not determined the length of the outage, nor taken appropriate steps to mitigate the issue.
View Details
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: The observation highlights deficiencies in system controls, such as improper data formatting, inadequate backup procedures, and non-validated software usage, all of which directly impact data integrity and regulatory compliance.
Excerpt: The information presented is displayed in metadata format in a tabular layout, which does not assure that the data is readable and complete.
View Details
Control and maintenance of (b) (4) (b) (4) are deficient
Janssen Biopharmaceuticals, Inc.		 01 Nov 2024 Normal Justification: The observation highlights deficiencies in control and maintenance, directly pointing to issues within system controls.
Excerpt: Control and maintenance...deficient. Specifically, from 2022 to 2024, a total of 68 events occurred...
View Details
Input to and output from the computer and records or data are not checked for accuracy
Eugia US Manufacturing LLC		 22 Dec 2023 Normal Justification: The observation indicates that controls to manage data within the NetSCADA system are either inadequate or not properly implemented, affecting system reliability.
Excerpt: It is unclear how this data were acquired in this system and whether or not there are controls in place to avoid the addition or deletion of data.
View Details
Raw material management is inadequate
Suzhou Suncadia Biopharmaceuticals Co., Ltd.		 14 Dec 2023 Normal Justification: The ERP system failed to recognize and flag that China-only material was being used in a US-destined batch, indicating insufficient system control logic and configuration.
Excerpt: The GS ERP data management system is not designed to detect mix-ups of raw materials that are dedicated to either US or foreign markets.
View Details

Frequently Asked Questions

Heading 1

Heading 2

Heading 3

Heading 4

Heading 5
Heading 6

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.

Block quote

Ordered list

  1. Item 1
  2. Item 2
  3. Item 3

Unordered list

  • Item A
  • Item B
  • Item C

Text link

Bold text

Emphasis

Superscript

Subscript

Experience Leucine AI Powered pharma manufacturing
Request Consultation
300+ pharma facilities worldwide use Leucine to stay compliant. Talk to one of our expert consultants at Leucine to learn how.
Related Resources

View and learn more about FDA Inspections
with our comprehensive list of resources

Audit Readiness Checklist
Audit Readiness Checklist
Audit Readiness Checklist
Audit Readiness Checklist
Audit Readiness Checklist

100-point Post FDA Inspection

Ensure post-FDA inspection audit readiness with our 100-point checklist. Close inspection gaps, strengthen RCA & CAPA systems, reinforce data integrity, and align with FDA & EMA compliance standards.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

Top 5 Subsystems in 2025: Highest Impact Areas in FDA Inspection Preparation

Struggling with FDA inspection preparation? Discover the top 5 subsystems that trigger the most citations, and how to avoid them with FDA Tracker insights.

Read Now
Observations
Observations
Observations
Observations
Observations

How to Draft Effective Written Responses to FDA Form 483 Observations

Don’t risk escalation. Learn how to write a strong FDA 483 letter response with CAPAs, evidence & structure. Follow expert-backed best practices now.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

Avoid Common Pitfalls During US FDA Inspections

Discover essential insights for navigating US FDA inspections to ensure compliance and safety in your operations. Read the article for practical guidance.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

Understand what the FDA expects from your CAPA system and how to build one that ensures compliance, avoids failures, and drives quality excellence.

Worried about an FDA inspection? Learn what to expect, how to respond, and stay audit-ready with expert tips and tools to avoid Form 483s. Get ahead now.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

FDA CAPA Process: What the FDA Expects and How to Comply

Understand what the FDA expects from your CAPA system and how to build one that ensures compliance, avoids failures, and drives quality excellence.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

FDA 483 Response: What Happens After an FDA Inspection? From 483 to Final Enforcement Action

Learn how to craft a timely, effective FDA 483 response within 15 business days. Ensure compliance, avoid escalation, and protect product quality.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

What Triggers an FDA Audit: Understanding For-Cause Inspections and How to Respond

Learn why FDA audits happen and how to respond fast. Stay compliant, ensure data integrity, and build inspection readiness with real-time insights.

Read Now
Guidelines
Guidelines
Guidelines
Guidelines
Guidelines

The Complete Guide to FDA Inspection Readiness in 2025

Be inspection-ready every day. Download the FDA checklist and build a system that earns confidence—not citations—during your next audit.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

Who Can See FDA Form 483s, and What’s the Best FDA Inspection Database to Use?

Looking for FDA Form 483s? Learn who can access them and why FDA Tracker is the smartest FDA inspection database to stay audit-ready and compliant.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

What Is an FDA Warning Letter?

FDA warning letters signal serious compliance failures. Learn what they mean, what triggers them, and how to respond before it leads to regulatory action.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

FDA Form 483 vs. Warning Letter: Know the Difference Before It Costs You

Learn the difference between FDA 483 and warning letters, what triggers escalation, and how to avoid regulatory action with smart compliance strategies.

Read Now
Blogs
Blogs
Blogs
Blogs
Blogs

FDA Form 483: Meaning, Impact & How to Stay Ahead

A Form 483 signals FDA concerns that can trigger warning letters. Learn what it means, how to respond, and how to prevent it before it’s too late.

Read Now

Experience the Future
of Pharma Manufacturing.

Products

FDA Compliance Tools

Blogs & White Papers

MES Audit Readiness HubQMS - Excellence HubCleaning Validation - Excellence HubLaboratory Execution System Hub

Customer Support

About

Copyright 2024 Leucine