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

Analytics Overview

96
Form 483s Issued
16
483s converted to WL
113
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
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
9
0
José E Melendez
9
0
John Doe
9
0
Jane Doe
7
0
John Smith
6
0

Observations

View all 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
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: Inadequately trained personnel pose quality risks, necessitating a risk management approach.
Excerpt: You do not have any scientific rationale to support the qualification of your operators with kits that are not representative of your worst-case products.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Fareva Amboise		 16 Sep 2025 Normal Justification: The failure to incorporate specific aseptic area activities in risk assessments undermines the monitoring effectiveness.
Excerpt: The assessment QRM-00165 used to establish environmental monitoring procedures did not thoroughly consider activities in the aseptic area.
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

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Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
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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.

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Quality Risk Management

Overview

96
Form 483s Issued
16
483s converted to WL
113
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
9
0
José E Melendez
9
0
John Doe
9
0
Jane Doe
7
0
John Smith
6
0

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
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: Inadequately trained personnel pose quality risks, necessitating a risk management approach.
Excerpt: You do not have any scientific rationale to support the qualification of your operators with kits that are not representative of your worst-case products.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Fareva Amboise		 16 Sep 2025 Normal Justification: The failure to incorporate specific aseptic area activities in risk assessments undermines the monitoring effectiveness.
Excerpt: The assessment QRM-00165 used to establish environmental monitoring procedures did not thoroughly consider activities in the aseptic area.
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

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