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Sub System /
Data Integrity
Data Integrity
View Detailed Analysis

Analytics Overview

158
Form 483s Issued
25
483s converted to WL
221
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
View Form 483
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
View Form 483
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
17 Apr 2026
Novel Laboratories, Inc. d.b.a Lupin
Drugs
View Form 483
27 Mar 2026
Allure Labs, LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
25
7
José E Melendez
21
18
Arsen Karapetyan
13
0
Anastasia M Shields
13
7
Pratik S Upadhyay
12
5

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
OBJECTIVE 3: Data Integrity Audit
Not available		 29 Jun 2026 Normal Justification: Data integrity forms the backbone of reliable product data and its deficiencies can lead to significant compliance issues.
Excerpt: Examples of data integrity concerns include failure to scientifically justify not reporting relevant data, such as aberrant test results.
View Details
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards
Strides Pharma Science Ltd.		 20 May 2026 Normal Justification: Enabling untracked modifications undermines data integrity, highlighting a need for strict controls.
Excerpt: Analysts can alter peak integration parameters without audit trail, selecting favorable outcomes.
View Details
All records of production associated with a batch of drug product were not maintained
Strides Pharma Science Ltd.		 20 May 2026 Normal Justification: Data Integrity is essential as audit trails capture critical electronic records for verification of manufacturing processes.
Excerpt: Your firm failed to retain electronic audit trail data generated by manufacturing equipment for the required period.
View Details
Appropriate controls are not exercised over computers or related systems
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Lack of stringent control over audit trails compromises data integrity, essential for compliance with CGMP.
Excerpt: permits Quality Assurance does not require Quality Assurance to review audit trails electronically.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Alkem Laboratories Limited		 01 May 2026 Normal Justification: The observation indicates potential manipulation or lack of proper data handling in QC testing, tied to Data Integrity process.
Excerpt: Your Quality Unit lacks adequate oversight into the integrity of data pertaining to QC testing on UV Spectrometry.
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

158
Form 483s Issued
25
483s converted to WL
221
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
20 May 2026
Strides Pharma Science Ltd.
Drugs
View Form 483
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
View Form 483
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
17 Apr 2026
Novel Laboratories, Inc. d.b.a Lupin
Drugs
View Form 483
27 Mar 2026
Allure Labs, LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
25
7
José E Melendez
21
18
Arsen Karapetyan
13
0
Anastasia M Shields
13
7
Pratik S Upadhyay
12
5

Key Observations

TITLE/ COMPANY Issue Date Status Details
OBJECTIVE 3: Data Integrity Audit
Not available		 29 Jun 2026 Normal Justification: Data integrity forms the backbone of reliable product data and its deficiencies can lead to significant compliance issues.
Excerpt: Examples of data integrity concerns include failure to scientifically justify not reporting relevant data, such as aberrant test results.
View Details
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards
Strides Pharma Science Ltd.		 20 May 2026 Normal Justification: Enabling untracked modifications undermines data integrity, highlighting a need for strict controls.
Excerpt: Analysts can alter peak integration parameters without audit trail, selecting favorable outcomes.
View Details
All records of production associated with a batch of drug product were not maintained
Strides Pharma Science Ltd.		 20 May 2026 Normal Justification: Data Integrity is essential as audit trails capture critical electronic records for verification of manufacturing processes.
Excerpt: Your firm failed to retain electronic audit trail data generated by manufacturing equipment for the required period.
View Details
Appropriate controls are not exercised over computers or related systems
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Lack of stringent control over audit trails compromises data integrity, essential for compliance with CGMP.
Excerpt: permits Quality Assurance does not require Quality Assurance to review audit trails electronically.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Alkem Laboratories Limited		 01 May 2026 Normal Justification: The observation indicates potential manipulation or lack of proper data handling in QC testing, tied to Data Integrity process.
Excerpt: Your Quality Unit lacks adequate oversight into the integrity of data pertaining to QC testing on UV Spectrometry.
View Details

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