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Sub System /
Audit Management
Audit Management
View Detailed Analysis

Analytics Overview

20
Form 483s Issued
4
483s converted to WL
20
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
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
20 Sep 2024
Aarti Drugs Limited
Drugs
View Form 483
26 Jul 2024
Biocon Biologics Limited
Drugs
View Form 483
26 Jun 2024
Mylan Laboratories Limited (FDF-3)
Drugs
View Form 483
View Warning Letter
24 May 2024
Mylan Laboratories Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
4
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
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
Computerized systems lack controls and review of electronic data to prevent omissions in data.
Biocon Biologics Limited		 26 Jul 2024 Normal Justification: The failure to have detailed, software-specific audit procedures directly affects the completeness and accuracy of data reviews.
Excerpt: Audit trail review procedures for production software are general and do not contain instructions specific to the different software to ensure a thorough review of raw data.
View Details
Appropriate controls are not exercised over computers or related systems
Mylan Laboratories Limited (FDF-3)		 26 Jun 2024 Normal Justification: Breached auditing events indicate weaknesses in managing audits effectively.
Excerpt: Quality events relating to "Auditing Breached" documented on the audit trail.
View Details
Records associated with drug product production and control and within the retention period for such records, were not made readily available for authorized inspection.
Mylan Laboratories Limited		 24 May 2024 Normal Justification: Audit Management pertains to the observation due to complications in provision and management of audit-related documents.
Excerpt: These events and interactions detailed in this section introduced a delay in our ability to perform the remainder of the inspection in a timely and effective manner.
View Details

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Go back

Audit Management

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

Audit Management

Overview

20
Form 483s Issued
4
483s converted to WL
20
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
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
20 Sep 2024
Aarti Drugs Limited
Drugs
View Form 483
26 Jul 2024
Biocon Biologics Limited
Drugs
View Form 483
26 Jun 2024
Mylan Laboratories Limited (FDF-3)
Drugs
View Form 483
View Warning Letter
24 May 2024
Mylan Laboratories Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
4
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
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
Computerized systems lack controls and review of electronic data to prevent omissions in data.
Biocon Biologics Limited		 26 Jul 2024 Normal Justification: The failure to have detailed, software-specific audit procedures directly affects the completeness and accuracy of data reviews.
Excerpt: Audit trail review procedures for production software are general and do not contain instructions specific to the different software to ensure a thorough review of raw data.
View Details
Appropriate controls are not exercised over computers or related systems
Mylan Laboratories Limited (FDF-3)		 26 Jun 2024 Normal Justification: Breached auditing events indicate weaknesses in managing audits effectively.
Excerpt: Quality events relating to "Auditing Breached" documented on the audit trail.
View Details
Records associated with drug product production and control and within the retention period for such records, were not made readily available for authorized inspection.
Mylan Laboratories Limited		 24 May 2024 Normal Justification: Audit Management pertains to the observation due to complications in provision and management of audit-related documents.
Excerpt: These events and interactions detailed in this section introduced a delay in our ability to perform the remainder of the inspection in a timely and effective manner.
View Details

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