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Sub System /
Data Integrity
Data Integrity
View Detailed Analysis

Analytics Overview

124
Form 483s Issued
25
483s converted to WL
182
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 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
View Form 483
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
24
7
José E Melendez
21
18
Arsen Karapetyan
13
0
Anastasia M Shields
12
7
Pratik S Upadhyay
12
5

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Production records do not contain complete information relating to the production and control of each batch
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The uncontrolled disposal of original printouts and lack of contemporaneous documentation highlights data integrity concerns.
Excerpt: Allowing for uncontrolled disposal of CGMP documentation with no Quality Unit oversight.
View Details
Established laboratory control mechanisms are not followed
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Deviations observed during testing directly impact the accuracy and reliability of laboratory data, reflecting data integrity issues.
Excerpt: This improper handling technique compromises the accuracy and reliability of the verification step, which is critical for ensuring data integrity.
View Details
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Backdating of records and discrepancies between stated and actual test durations directly relate to data integrity concerns.
Excerpt: Backdating was observed in the document "Microbiological Examination of Finished Product"; discrepancies in dissolution test duration.
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: The observation highlights lapses in controlling access to computer systems, critical for ensuring data integrity, particularly with shared credentials and deletion capabilities.
Excerpt: The computer system has a shared username and password for the department. In addition, the same computer has permissions for deleting files.
View Details
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Data integrity process is undermined by the absence of accurate cross-verification between Observer and Reviewer records.
Excerpt: According to the Head of Quality, microbial data is verified by a QC Supervisor in CaliberLIMS prior to release.
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.

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Data Integrity

Overview

124
Form 483s Issued
25
483s converted to WL
182
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 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
View Form 483
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
24
7
José E Melendez
21
18
Arsen Karapetyan
13
0
Anastasia M Shields
12
7
Pratik S Upadhyay
12
5

Key Observations

TITLE/ COMPANY Issue Date Status Details
Production records do not contain complete information relating to the production and control of each batch
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The uncontrolled disposal of original printouts and lack of contemporaneous documentation highlights data integrity concerns.
Excerpt: Allowing for uncontrolled disposal of CGMP documentation with no Quality Unit oversight.
View Details
Established laboratory control mechanisms are not followed
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Deviations observed during testing directly impact the accuracy and reliability of laboratory data, reflecting data integrity issues.
Excerpt: This improper handling technique compromises the accuracy and reliability of the verification step, which is critical for ensuring data integrity.
View Details
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Backdating of records and discrepancies between stated and actual test durations directly relate to data integrity concerns.
Excerpt: Backdating was observed in the document "Microbiological Examination of Finished Product"; discrepancies in dissolution test duration.
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: The observation highlights lapses in controlling access to computer systems, critical for ensuring data integrity, particularly with shared credentials and deletion capabilities.
Excerpt: The computer system has a shared username and password for the department. In addition, the same computer has permissions for deleting files.
View Details
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Data integrity process is undermined by the absence of accurate cross-verification between Observer and Reviewer records.
Excerpt: According to the Head of Quality, microbial data is verified by a QC Supervisor in CaliberLIMS prior to release.
View Details

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