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Sub System /
Data Integrity
Data Integrity
View Detailed Analysis

Analytics Overview

122
Form 483s Issued
25
483s converted to WL
178
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
22
7
José E Melendez
21
18
Jane Smith
14
0
John Doe
14
0
Arsen Karapetyan
13
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: Uncontrolled evidence of test results and undocumented data flow highlight critical shortcomings in data integrity processes.
Excerpt: Numerous uncontrolled notebook pages containing analytical test results for APIs and API intermediates manufactured.
View Details
Your Quality Unit failed to adequately control documents.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: Non-compliance with ALCOA+ and lack of oversight on information recording clearly point to data integrity issues.
Excerpt: raw test data showed significant variation in test results...no explanation about documentation of testing activities.
View Details
Appropriate controls were not exercised over computerized systems
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: Data integrity was compromised due to unauthorized access capabilities, emphasizing the need for robust controls.
Excerpt: Users had permissions to modify sequence from finish product, in-process, stability, and raw material testing results compromising the integrity and traceability of the data being recorded.
View Details
Procedures for the preparation of master production and control records are not described in a written procedure
Fareva Amboise		 16 Sep 2025 Normal Justification: Data integrity is compromised when original records can be destroyed without traceable oversight, highlighting the need for controlled document destruction processes.
Excerpt: Employees have uncontrolled access to paper shredders located in the production and laboratory areas.
View Details
Appropriate controls are not exercised over computers or related systems
Fareva Amboise		 16 Sep 2025 Normal Justification: The issue of unauthorized changes and lack of audit trails directly impacts data integrity, undermining compliance and trust in records.
Excerpt: User can change time and date and clear stored data on the Non-Viable Particle Counter. No audit trail on tablet press.
View Details

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Data Integrity

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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Data Integrity

Overview

122
Form 483s Issued
25
483s converted to WL
178
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
22
7
José E Melendez
21
18
Jane Smith
14
0
John Doe
14
0
Arsen Karapetyan
13
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: Uncontrolled evidence of test results and undocumented data flow highlight critical shortcomings in data integrity processes.
Excerpt: Numerous uncontrolled notebook pages containing analytical test results for APIs and API intermediates manufactured.
View Details
Your Quality Unit failed to adequately control documents.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: Non-compliance with ALCOA+ and lack of oversight on information recording clearly point to data integrity issues.
Excerpt: raw test data showed significant variation in test results...no explanation about documentation of testing activities.
View Details
Appropriate controls were not exercised over computerized systems
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: Data integrity was compromised due to unauthorized access capabilities, emphasizing the need for robust controls.
Excerpt: Users had permissions to modify sequence from finish product, in-process, stability, and raw material testing results compromising the integrity and traceability of the data being recorded.
View Details
Procedures for the preparation of master production and control records are not described in a written procedure
Fareva Amboise		 16 Sep 2025 Normal Justification: Data integrity is compromised when original records can be destroyed without traceable oversight, highlighting the need for controlled document destruction processes.
Excerpt: Employees have uncontrolled access to paper shredders located in the production and laboratory areas.
View Details
Appropriate controls are not exercised over computers or related systems
Fareva Amboise		 16 Sep 2025 Normal Justification: The issue of unauthorized changes and lack of audit trails directly impacts data integrity, undermining compliance and trust in records.
Excerpt: User can change time and date and clear stored data on the Non-Viable Particle Counter. No audit trail on tablet press.
View Details

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