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Sub System /
System Controls
System Controls
View Detailed Analysis

Analytics Overview

3
Form 483s Issued
0
483s converted to WL
3
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
15 Nov 2024
Exela Pharma Sciences LLC
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
23 Feb 2001
Eli Lilly & Company
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
James R Birkenstamm
1
0
Joan Cantellops
1
0
Logan Williams
1
0
Megan Ziegler
1
0
Daniel L Zheng
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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
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

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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

3
Form 483s Issued
0
483s converted to WL
3
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
15 Nov 2024
Exela Pharma Sciences LLC
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
23 Feb 2001
Eli Lilly & Company
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
James R Birkenstamm
1
0
Joan Cantellops
1
0
Logan Williams
1
0
Megan Ziegler
1
0
Daniel L Zheng
1
0

Key Observations

TITLE/ COMPANY Issue Date Status 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
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

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