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Sub System /
Data Integrity
Data Integrity
View Detailed Analysis

Analytics Overview

98
Form 483s Issued
25
483s converted to WL
151
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
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
21
18
Justin A Boyd
20
7
Arsen Karapetyan
13
0
Anastasia M Shields
12
7
Pratik S Upadhyay
11
5

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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
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
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: Data integrity is directly affected due to unreviewed raw data and lack of understanding of errors by the Quality Unit.
Excerpt: Your Quality Unit does not always review all electronic raw data generated by all HPLC/GC laboratory equipment.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Cohance Lifesciences Limited		 12 Aug 2025 Normal Justification: Shared login credentials compromise data security, affecting data integrity.
Excerpt: Same User ID and passwords shared amongst operators, supervisors, and managers for login.
View Details
OBSERVATION 4 The firm does not maintain complete and accurate batch production and control records for its drug products.
Not available		 01 Aug 2025 Normal Justification: Data Integrity ensures reliability and authenticity of records; breaches directly lead to compliance risks.
Excerpt: Operators stated records were written post-shift, allowing potential substitutions and errors.
View Details

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Go back

Data Integrity

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

Data Integrity

Overview

98
Form 483s Issued
25
483s converted to WL
151
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
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
21
18
Justin A Boyd
20
7
Arsen Karapetyan
13
0
Anastasia M Shields
12
7
Pratik S Upadhyay
11
5

Key Observations

TITLE/ COMPANY Issue Date Status 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
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
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: Data integrity is directly affected due to unreviewed raw data and lack of understanding of errors by the Quality Unit.
Excerpt: Your Quality Unit does not always review all electronic raw data generated by all HPLC/GC laboratory equipment.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Cohance Lifesciences Limited		 12 Aug 2025 Normal Justification: Shared login credentials compromise data security, affecting data integrity.
Excerpt: Same User ID and passwords shared amongst operators, supervisors, and managers for login.
View Details
OBSERVATION 4 The firm does not maintain complete and accurate batch production and control records for its drug products.
Not available		 01 Aug 2025 Normal Justification: Data Integrity ensures reliability and authenticity of records; breaches directly lead to compliance risks.
Excerpt: Operators stated records were written post-shift, allowing potential substitutions and errors.
View Details

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