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Sub System /
Data Integrity
Data Integrity
View Detailed Analysis

Analytics Overview

91
Form 483s Issued
25
483s converted to WL
143
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
01 Aug 2025
Not available
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
View Warning Letter
20 Nov 2024
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
35
16
Arsen Karapetyan
16
0
Pratik S Upadhyay
16
9
Anastasia M Shields
12
7
Teresa I Navas
11
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Missing documentation for interrupted analyses is linked to data integrity process lapses.
Excerpt: C. We observed at least 36 sample set projects where interruptions occurred with inadequate investigatory follow-up or documentation.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: The lack of review and potential data manipulation signifies core deficiencies in data integrity processes.
Excerpt: Results had been altered from over the action limit (non-conforming) to below the action limit.
View Details
QUALITY SYSTEM
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Ensures that comprehensive data review by QA prevents data discrepancies and maintains process integrity.
Excerpt: Comprehensive reviews of raw manufacturing and analytical data are not performed by the QA unit.
View Details
The quality control unit lacks authority to review production records to assure that no errors have occurred.
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: Data Integrity is crucial as the observation cites manually entered data and missing audit trails compromising data accuracy.
Excerpt: GJC100-01 and GJC101-01 do not have an audit trail, do not save data, requiring manual input.
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

91
Form 483s Issued
25
483s converted to WL
143
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
01 Aug 2025
Not available
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
View Warning Letter
20 Nov 2024
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
35
16
Arsen Karapetyan
16
0
Pratik S Upadhyay
16
9
Anastasia M Shields
12
7
Teresa I Navas
11
2

Key Observations

TITLE/ COMPANY Issue Date Status 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Missing documentation for interrupted analyses is linked to data integrity process lapses.
Excerpt: C. We observed at least 36 sample set projects where interruptions occurred with inadequate investigatory follow-up or documentation.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: The lack of review and potential data manipulation signifies core deficiencies in data integrity processes.
Excerpt: Results had been altered from over the action limit (non-conforming) to below the action limit.
View Details
QUALITY SYSTEM
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Ensures that comprehensive data review by QA prevents data discrepancies and maintains process integrity.
Excerpt: Comprehensive reviews of raw manufacturing and analytical data are not performed by the QA unit.
View Details
The quality control unit lacks authority to review production records to assure that no errors have occurred.
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: Data Integrity is crucial as the observation cites manually entered data and missing audit trails compromising data accuracy.
Excerpt: GJC100-01 and GJC101-01 do not have an audit trail, do not save data, requiring manual input.
View Details

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