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Sub System /
Audit Management
Audit Management
View Detailed Analysis

Analytics Overview

27
Form 483s Issued
5
483s converted to WL
27
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
29 Jun 2026
Vascular Solutions, LLC
Drugs
10 Mar 2026
Hospira, Inc.
Drugs
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs
17 Jun 2025
Clongen Laboratories, LLC
Drugs

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
TITLE/ COMPANY Issue Date Status Details
Pre-License Inspection #1
Vascular Solutions, LLC
29 Jun 2026 Normal Justification: Pre-License Inspection #1 implies serious gaps in audit management, considering the volume of observations.
Excerpt: Form FDA 483 issued with 14 observations
View Details
Your firm lacks adequate quality oversight to ensure Acceptable Quality Level (AQL) samples are taken
Hospira, Inc.
10 Mar 2026 Normal Justification: As per SOP-96072, auditing is a control point for sampling adherence but failed, necessitating process audit improvement.
Excerpt: Auditing of Production Operations, Section E.3 clarifies representation requirement, suggesting auditing lapses contributed.
View 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

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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.

Audit Management

Overview

27
Form 483s Issued
5
483s converted to WL
27
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
29 Jun 2026
Vascular Solutions, LLC
Drugs
10 Mar 2026
Hospira, Inc.
Drugs
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs
17 Jun 2025
Clongen Laboratories, LLC
Drugs

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
Pre-License Inspection #1
Vascular Solutions, LLC
29 Jun 2026 Normal Justification: Pre-License Inspection #1 implies serious gaps in audit management, considering the volume of observations.
Excerpt: Form FDA 483 issued with 14 observations
View Details
Your firm lacks adequate quality oversight to ensure Acceptable Quality Level (AQL) samples are taken
Hospira, Inc.
10 Mar 2026 Normal Justification: As per SOP-96072, auditing is a control point for sampling adherence but failed, necessitating process audit improvement.
Excerpt: Auditing of Production Operations, Section E.3 clarifies representation requirement, suggesting auditing lapses contributed.
View 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

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Related Resources

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