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Sub System /
Complaint Management
Complaint Management
View Detailed Analysis

Analytics Overview

106
Form 483s Issued
16
483s converted to WL
134
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
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
View Form 483
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
27 Mar 2026
Charles River Laboratories, Inc.
Drugs
View Form 483
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
View Form 483
11 Mar 2026
VET4U, LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
18
9
Pratik S Upadhyay
7
3
Taichun Qin
6
3
Pratik S. Upadhyay
5
0
Arsen Karapetyan
5
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
OBJECTIVE 1d: Adequate procedures exist for batch release, change management, and investigating failures, deviations, complaints, and adverse events.
Not available		 29 Jun 2026 Normal Justification: Complaint handling and ADE reporting systems directly influence regulatory compliance and product tracking.
Excerpt: If significant problems are found with the establishment's existing complaint handling and reporting procedures...
View Details
Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Complaint Management process is directly linked as the core issue involves lapse in stipulated complaint handling procedure.
Excerpt: "Procedures describing the handling of written and oral complaints related to drug products are not written or followed."
View Details
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Observation highlights failure in investigating complaints, a core aspect of complaint management processes.
Excerpt: Complaints that identify a product but not a specific batch are not fully investigated.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: The high number of complaints indicates a failure in effectively analyzing and acting upon product feedback related to equipment.
Excerpt: Approximately 225 complaints related to the displacement of stoppers within the last 4 years.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Alkem Laboratories Limited		 01 May 2026 Normal Justification: The persistence of resolved complaints pointed to gaps in handling processes and corrective action timelines.
Excerpt: Your firm received a complaint from the US market on July 29, 2022, regarding black spots and metal particle.
View Details

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Complaint 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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Complaint Management

Overview

106
Form 483s Issued
16
483s converted to WL
134
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
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
View Form 483
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
27 Mar 2026
Charles River Laboratories, Inc.
Drugs
View Form 483
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
View Form 483
11 Mar 2026
VET4U, LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
18
9
Pratik S Upadhyay
7
3
Taichun Qin
6
3
Pratik S. Upadhyay
5
0
Arsen Karapetyan
5
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
OBJECTIVE 1d: Adequate procedures exist for batch release, change management, and investigating failures, deviations, complaints, and adverse events.
Not available		 29 Jun 2026 Normal Justification: Complaint handling and ADE reporting systems directly influence regulatory compliance and product tracking.
Excerpt: If significant problems are found with the establishment's existing complaint handling and reporting procedures...
View Details
Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Complaint Management process is directly linked as the core issue involves lapse in stipulated complaint handling procedure.
Excerpt: "Procedures describing the handling of written and oral complaints related to drug products are not written or followed."
View Details
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Observation highlights failure in investigating complaints, a core aspect of complaint management processes.
Excerpt: Complaints that identify a product but not a specific batch are not fully investigated.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: The high number of complaints indicates a failure in effectively analyzing and acting upon product feedback related to equipment.
Excerpt: Approximately 225 complaints related to the displacement of stoppers within the last 4 years.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Alkem Laboratories Limited		 01 May 2026 Normal Justification: The persistence of resolved complaints pointed to gaps in handling processes and corrective action timelines.
Excerpt: Your firm received a complaint from the US market on July 29, 2022, regarding black spots and metal particle.
View Details

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