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

Analytics Overview

40
Form 483s Issued
10
483s converted to WL
42
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
20 May 2026
Strides Pharma Science Ltd.
Drugs
27 Mar 2026
Allure Labs, LLC
Drugs
23 Mar 2026
Cerovene Inc.
Drugs
20 Mar 2026
Abbisko Therapeutics Co., Ltd.
Drugs
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs

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
TITLE/ COMPANY Issue Date Status Details
Your firm failed to exercise controls over computerized manufacturing equipment
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: Improper user access controls allow unauthorized recipe management, undermining system integrity.
Excerpt: Recipe creation should be restricted to Quality Assurance personnel.
View Details
Appropriate controls are not exercised over computers or related systems
Allure Labs, LLC
27 Mar 2026 Normal Justification: Compromised access control due to multiple accounts with elevated privileges, heightening the risk of unauthorized data modifications.
Excerpt: QC Manager has two HPLC (b)(4) user accounts, one as "system", and the other as "administrator".
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
Cerovene Inc.
23 Mar 2026 Normal Justification: Shared credentials and system access without authentication point to failures in user access control.
Excerpt: The QC Manager was able to change the date and time from the balance without log-in credentials.
View Details
Failure to ensure the study is conducted in accordance with the protocol and/or investigational plan
Abbisko Therapeutics Co., Ltd.
20 Mar 2026 Normal Justification: User Access and Controls is fundamental because improper role settings allowed unauthorized access, impacting data integrity.
Excerpt: This vendor made an error while updating permissions for user roles for the study which granted the blinded PV staff access.
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.
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

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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

40
Form 483s Issued
10
483s converted to WL
42
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
20 May 2026
Strides Pharma Science Ltd.
Drugs
27 Mar 2026
Allure Labs, LLC
Drugs
23 Mar 2026
Cerovene Inc.
Drugs
20 Mar 2026
Abbisko Therapeutics Co., Ltd.
Drugs
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs

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
Your firm failed to exercise controls over computerized manufacturing equipment
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: Improper user access controls allow unauthorized recipe management, undermining system integrity.
Excerpt: Recipe creation should be restricted to Quality Assurance personnel.
View Details
Appropriate controls are not exercised over computers or related systems
Allure Labs, LLC
27 Mar 2026 Normal Justification: Compromised access control due to multiple accounts with elevated privileges, heightening the risk of unauthorized data modifications.
Excerpt: QC Manager has two HPLC (b)(4) user accounts, one as "system", and the other as "administrator".
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
Cerovene Inc.
23 Mar 2026 Normal Justification: Shared credentials and system access without authentication point to failures in user access control.
Excerpt: The QC Manager was able to change the date and time from the balance without log-in credentials.
View Details
Failure to ensure the study is conducted in accordance with the protocol and/or investigational plan
Abbisko Therapeutics Co., Ltd.
20 Mar 2026 Normal Justification: User Access and Controls is fundamental because improper role settings allowed unauthorized access, impacting data integrity.
Excerpt: This vendor made an error while updating permissions for user roles for the study which granted the blinded PV staff access.
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.
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

Frequently Asked Questions

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