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Sub System /
Quality Risk Management
Quality Risk Management
View Detailed Analysis

Analytics Overview

78
Form 483s Issued
16
483s converted to WL
95
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
13 Aug 2025
Zydus Lifesciences Limited
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Pratik S Upadhyay
5
2
Nibin Varghese
4
0
Joseph A Piechocki
4
3
Justin A Boyd
4
2
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Hetero Labs Limited, Unit-IX
26 Sep 2025 Normal Justification: Using an unregistered lab without formal agreements points to deficiencies in assessing and managing quality risks.
Excerpt: Unregistered laboratory is not referenced in any of your Drug Master Files (DMF) filed with FDA.
View Details
The risk assessment for viral control at Dr. Reddy's Laboratories is inadequate
Dr. Reddy's Laboratories, LTD, Biologics
12 Sep 2025 Normal Justification: Quality Risk Management is relevant as the current risk assessment fails to identify and control critical viral contamination risks.
Excerpt: The risk assessment for viral control is inadequate to mitigate potential virus cross-contamination risk.
View Details
Failure to establish adequate specifications, sampling plans, and testing procedures to ensure that raw materials and APIs meet accepted quality standards
Dr. Reddy's Laboratories (EU) Ltd.
05 Sep 2025 Normal Justification: Failure to determine microbial testing requirements reflects a gap in risk management related to aqueous material use.
Excerpt: Your firm should have conducted a risk assessment to determine appropriate microbial testing requirements.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Zydus Lifesciences Limited
13 Aug 2025 Normal Justification: The observation highlights a failure in assessing and mitigating risks associated with product impurities, central to Quality Risk Management.
Excerpt: market action for batches of US product that failed to meet the specification limit for Drug Substance Related Impurities.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
GenoGenix, LLC
18 Jul 2025 Normal Justification: The observation highlights failures in quality oversight, a core component of Quality Risk Management, impacting compliance.
Excerpt: Your QU has not established control over: The release specifications of finished drug products.
View Details

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Quality Risk Management

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Quality Risk Management

Overview

78
Form 483s Issued
16
483s converted to WL
95
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
13 Aug 2025
Zydus Lifesciences Limited
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Pratik S Upadhyay
5
2
Nibin Varghese
4
0
Joseph A Piechocki
4
3
Justin A Boyd
4
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Hetero Labs Limited, Unit-IX
26 Sep 2025 Normal Justification: Using an unregistered lab without formal agreements points to deficiencies in assessing and managing quality risks.
Excerpt: Unregistered laboratory is not referenced in any of your Drug Master Files (DMF) filed with FDA.
View Details
The risk assessment for viral control at Dr. Reddy's Laboratories is inadequate
Dr. Reddy's Laboratories, LTD, Biologics
12 Sep 2025 Normal Justification: Quality Risk Management is relevant as the current risk assessment fails to identify and control critical viral contamination risks.
Excerpt: The risk assessment for viral control is inadequate to mitigate potential virus cross-contamination risk.
View Details
Failure to establish adequate specifications, sampling plans, and testing procedures to ensure that raw materials and APIs meet accepted quality standards
Dr. Reddy's Laboratories (EU) Ltd.
05 Sep 2025 Normal Justification: Failure to determine microbial testing requirements reflects a gap in risk management related to aqueous material use.
Excerpt: Your firm should have conducted a risk assessment to determine appropriate microbial testing requirements.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Zydus Lifesciences Limited
13 Aug 2025 Normal Justification: The observation highlights a failure in assessing and mitigating risks associated with product impurities, central to Quality Risk Management.
Excerpt: market action for batches of US product that failed to meet the specification limit for Drug Substance Related Impurities.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
GenoGenix, LLC
18 Jul 2025 Normal Justification: The observation highlights failures in quality oversight, a core component of Quality Risk Management, impacting compliance.
Excerpt: Your QU has not established control over: The release specifications of finished drug products.
View Details

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