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User Access and Controls
User Access and Controls
View Detailed Analysis

Analytics Overview

28
Form 483s Issued
10
483s converted to WL
29
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
04 Jul 2025
Alvotech HF
Drugs
02 May 2025
Concord Biotech Limited
Drugs
06 Nov 2024
ARUP Laboratories, Inc.
Drugs
27 Aug 2024
Baxter Oncology GmbH
Drugs
26 Jun 2024
Mylan Laboratories Limited (FDF-3)
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Nibin Varghese
4
1
Kathryn King, PhD, Biologist
2
0
Della Shin, PhD, Pharmaceutical Scientist
2
0
Ekaterina Allen, PhD, Pharmaceutical Scientist
2
0
Hyung-yul Lee, Ph.D, Pharmaceutical Scientist
2
0
TITLE/ COMPANY Issue Date Status 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
Your firm's documentation practices are deficient.
Alvotech HF
04 Jul 2025 Normal Justification: User Access and Controls are essential to maintaining security and confidentiality of GMP documentation.
Excerpt: Your firm failed to implement appropriate access control over GMP records.
View Details
Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data
Concord Biotech Limited
02 May 2025 Normal Justification: The lack of individual user credentials is indicative of a significant gap in the 'User Access and Controls' process.
Excerpt: Analyst can login with common username "operator"; your Quality Assurance department uses a common username "CBL\qa".
View Details
(b) (4) are not checked for accuracy.
ARUP Laboratories, Inc.
06 Nov 2024 Normal Justification: The observation focuses on failure to restrict access permissions, a critical aspect of User Access and Controls.
Excerpt: Your firm was unaware that the employee had the permissions to (b) (4) a donation (DEV-2024-0262).
View Details
Standard operating procedures (SOP) supporting manufacture of drug product are deficient or are not followed
Baxter Oncology GmbH
27 Aug 2024 Normal Justification: Access control failures could lead to unqualified personnel entering critical GMP areas, risking compliance.
Excerpt: "Access control system failing to track when a revocation of access rights is performed"
View Details

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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.

User Access and Controls

Overview

28
Form 483s Issued
10
483s converted to WL
29
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
04 Jul 2025
Alvotech HF
Drugs
02 May 2025
Concord Biotech Limited
Drugs
06 Nov 2024
ARUP Laboratories, Inc.
Drugs
27 Aug 2024
Baxter Oncology GmbH
Drugs
26 Jun 2024
Mylan Laboratories Limited (FDF-3)
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Nibin Varghese
4
1
Kathryn King, PhD, Biologist
2
0
Della Shin, PhD, Pharmaceutical Scientist
2
0
Ekaterina Allen, PhD, Pharmaceutical Scientist
2
0
Hyung-yul Lee, Ph.D, Pharmaceutical Scientist
2
0

Key Observations

TITLE/ COMPANY Issue Date Status 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
Your firm's documentation practices are deficient.
Alvotech HF
04 Jul 2025 Normal Justification: User Access and Controls are essential to maintaining security and confidentiality of GMP documentation.
Excerpt: Your firm failed to implement appropriate access control over GMP records.
View Details
Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data
Concord Biotech Limited
02 May 2025 Normal Justification: The lack of individual user credentials is indicative of a significant gap in the 'User Access and Controls' process.
Excerpt: Analyst can login with common username "operator"; your Quality Assurance department uses a common username "CBL\qa".
View Details
(b) (4) are not checked for accuracy.
ARUP Laboratories, Inc.
06 Nov 2024 Normal Justification: The observation focuses on failure to restrict access permissions, a critical aspect of User Access and Controls.
Excerpt: Your firm was unaware that the employee had the permissions to (b) (4) a donation (DEV-2024-0262).
View Details
Standard operating procedures (SOP) supporting manufacture of drug product are deficient or are not followed
Baxter Oncology GmbH
27 Aug 2024 Normal Justification: Access control failures could lead to unqualified personnel entering critical GMP areas, risking compliance.
Excerpt: "Access control system failing to track when a revocation of access rights is performed"
View Details

Frequently Asked Questions

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Related Resources

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