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Sub System /
Audit Management
Audit Management
View Detailed Analysis

Analytics Overview

25
Form 483s Issued
5
483s converted to WL
25
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
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
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
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
View Warning Letter
20 Sep 2024
Aarti Drugs Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
3
1
Pratik S Upadhyay
2
1
Teresa I Navas
2
0
Arsen Karapetyan
1
0
Brandon L Mariner
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Evidences cited displaying assembled responses
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: The observation implies issues with procedural standardization and governance, which are key components of audit management.
Excerpt: Standardizing uniform tested synopsis concretely illustrating examined convergence signals integrated reverberationally biocollectively enduring isometric governance benchmarks.
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: Audit management is compromised due to exclusion of Quality Walkthrough data from determining audit frequency.
Excerpt: Your firm’s self-inspection program fails to effectively utilize quality data from ongoing monitoring activities.
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: Unrestricted access to modify audit trails compromises the data integrity and audit reliability.
Excerpt: Packaging Supervisor was able to cut and delete logged software audit trail data.
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: Audit Management is fundamentally linked to the issue of audit trail invisibility and lack of oversight cited in the observation.
Excerpt: Quality personnel do not review audit trails that document parameters and changes. No audit trail for GJC100-01 and GJC101-01.
View Details
Your internal audit is not effective to verify compliance with the principles of CGMP for APIs.
Aarti Drugs Limited		 20 Sep 2024 Normal Justification: Audit Management is directly linked as the observation highlights deficiencies in the audit execution and auditor qualifications.
Excerpt: Your firm’s internal audit is not robust and are all preannounced audits based on a predefined checklist.
View Details

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Audit Management

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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Audit Management

Overview

25
Form 483s Issued
5
483s converted to WL
25
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
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
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
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
View Warning Letter
20 Sep 2024
Aarti Drugs Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
3
1
Pratik S Upadhyay
2
1
Teresa I Navas
2
0
Arsen Karapetyan
1
0
Brandon L Mariner
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Evidences cited displaying assembled responses
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: The observation implies issues with procedural standardization and governance, which are key components of audit management.
Excerpt: Standardizing uniform tested synopsis concretely illustrating examined convergence signals integrated reverberationally biocollectively enduring isometric governance benchmarks.
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: Audit management is compromised due to exclusion of Quality Walkthrough data from determining audit frequency.
Excerpt: Your firm’s self-inspection program fails to effectively utilize quality data from ongoing monitoring activities.
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: Unrestricted access to modify audit trails compromises the data integrity and audit reliability.
Excerpt: Packaging Supervisor was able to cut and delete logged software audit trail data.
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: Audit Management is fundamentally linked to the issue of audit trail invisibility and lack of oversight cited in the observation.
Excerpt: Quality personnel do not review audit trails that document parameters and changes. No audit trail for GJC100-01 and GJC101-01.
View Details
Your internal audit is not effective to verify compliance with the principles of CGMP for APIs.
Aarti Drugs Limited		 20 Sep 2024 Normal Justification: Audit Management is directly linked as the observation highlights deficiencies in the audit execution and auditor qualifications.
Excerpt: Your firm’s internal audit is not robust and are all preannounced audits based on a predefined checklist.
View Details

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