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Sub System /
User Access and Controls
User Access and Controls
View Detailed Analysis

Analytics Overview

34
Form 483s Issued
10
483s converted to WL
36
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
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
04 Jul 2025
Alvotech HF
Drugs
View Form 483
02 May 2025
Concord Biotech Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Nibin Varghese
5
1
Angelica M. Hernandez
3
0
Ekaterina Allen, PhD, Pharmaceutical Scientist
2
0
Alan A. Rivera
2
0
Della Shin, PhD, Pharmaceutical Scientist
2
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.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Shared credentials and excessive permissions illustrate a lack of controlled user access management.
Excerpt: The computer system has a shared username and password for the department.
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.
Gland Chemicals Private Limited		 27 Nov 2025 Normal Justification: The issue directly relates to user roles in the software, affecting how access controls were implemented for external personnel.
Excerpt: Your customer was assigned with an "analyst" role and had access to work with your Empower 3.8.1 software HPLC/GC analytical data.
View Details
Aseptic processing areas deficient regarding system for monitoring environmental conditions.
Gland Chemicals Private Limited		 27 Nov 2025 Normal Justification: Observation of personnel bypassing access controls highlights issues with user access and control systems.
Excerpt: Firm personnel were observed bypassing the access-controlled card readers.
View Details
Appropriate controls were not exercised over computerized systems
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: User Access and Controls are crucial in preventing unauthorized modifications, as evidenced by the excessive privileges observed.
Excerpt: Your SCADA system had user accounts with extensive administrative privileges, including the ability to modify/edit critical process parameters and recipes without adequate oversight.
View Details
Your firm failed to exercise appropriate controls to protect the electronic data acquisition and process control systems
Alvotech HF		 04 Jul 2025 Normal Justification: Access controls are crucial for ensuring accountability and preventing unauthorized system changes.
Excerpt: Your staff used a shared username and password to log into a lantopi.
View Details

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Uncover Trends: FDA Investigator profiles & Observations.
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User Access and Controls

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

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User Access and Controls

Overview

34
Form 483s Issued
10
483s converted to WL
36
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
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
04 Jul 2025
Alvotech HF
Drugs
View Form 483
02 May 2025
Concord Biotech Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Nibin Varghese
5
1
Angelica M. Hernandez
3
0
Ekaterina Allen, PhD, Pharmaceutical Scientist
2
0
Alan A. Rivera
2
0
Della Shin, PhD, Pharmaceutical Scientist
2
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.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Shared credentials and excessive permissions illustrate a lack of controlled user access management.
Excerpt: The computer system has a shared username and password for the department.
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.
Gland Chemicals Private Limited		 27 Nov 2025 Normal Justification: The issue directly relates to user roles in the software, affecting how access controls were implemented for external personnel.
Excerpt: Your customer was assigned with an "analyst" role and had access to work with your Empower 3.8.1 software HPLC/GC analytical data.
View Details
Aseptic processing areas deficient regarding system for monitoring environmental conditions.
Gland Chemicals Private Limited		 27 Nov 2025 Normal Justification: Observation of personnel bypassing access controls highlights issues with user access and control systems.
Excerpt: Firm personnel were observed bypassing the access-controlled card readers.
View Details
Appropriate controls were not exercised over computerized systems
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: User Access and Controls are crucial in preventing unauthorized modifications, as evidenced by the excessive privileges observed.
Excerpt: Your SCADA system had user accounts with extensive administrative privileges, including the ability to modify/edit critical process parameters and recipes without adequate oversight.
View Details
Your firm failed to exercise appropriate controls to protect the electronic data acquisition and process control systems
Alvotech HF		 04 Jul 2025 Normal Justification: Access controls are crucial for ensuring accountability and preventing unauthorized system changes.
Excerpt: Your staff used a shared username and password to log into a lantopi.
View Details

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