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Sub System /
Complaint Management
Complaint Management
View Detailed Analysis

Analytics Overview

89
Form 483s Issued
16
483s converted to WL
111
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
11 Mar 2026
VET4U, LLC
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
View Form 483
21 Nov 2025
Lupin Limited
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
Rajiv R. Srivastava
5
0
Arsen Karapetyan
4
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Your firm does not have adequate systems and processes to enable compliance with the verification requirements of section 582(c) of Federal Food, Drug, and Cosmetic Act
VET4U, LLC		 11 Mar 2026 Normal Justification: Complaint Management is essential as it involves the recording and response to notifications of illegitimate products.
Excerpt: Your Quality Document 440, titled Records, last reviewed on 06/02/2025, does not establish systems and processes to ensure records...
View Details
Complaints records are deficient in that they do not include the findings of the investigation and follow-up.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: The observation highlights shortcomings in managing consumer complaints, directly relating to the Complaint Management process type.
Excerpt: Complaints records are deficient in that they do not include the findings of the investigation and follow-up.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Complaints about sub-potent or super-potent products were not adequately tested for potency, evidencing gaps in complaint management.
Excerpt: Complaints involving drug product efficacy were not tested for assay as part of your investigation.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Dr. Reddy's Laboratories Limited		 12 Dec 2025 Normal Justification: The observation states market complaints were mishandled, linking to complaint management processes.
Excerpt: You unsubstantiated the Market Complaints for the (b)(4) batches that were not part of this campaign.
View Details
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed
Lupin Limited		 21 Nov 2025 Normal Justification: The observation highlights significant shortcomings in handling complaints, crucial for identifying potential defects or safety issues.
Excerpt: Your Quality Unit failed to thoroughly investigate adverse drug events (ADE) and market complaints relating to Lack of Effect (LOE).
View Details

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Uncover Trends: FDA Investigator profiles & Observations.
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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

89
Form 483s Issued
16
483s converted to WL
111
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
11 Mar 2026
VET4U, LLC
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
View Form 483
21 Nov 2025
Lupin Limited
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
Rajiv R. Srivastava
5
0
Arsen Karapetyan
4
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm does not have adequate systems and processes to enable compliance with the verification requirements of section 582(c) of Federal Food, Drug, and Cosmetic Act
VET4U, LLC		 11 Mar 2026 Normal Justification: Complaint Management is essential as it involves the recording and response to notifications of illegitimate products.
Excerpt: Your Quality Document 440, titled Records, last reviewed on 06/02/2025, does not establish systems and processes to ensure records...
View Details
Complaints records are deficient in that they do not include the findings of the investigation and follow-up.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: The observation highlights shortcomings in managing consumer complaints, directly relating to the Complaint Management process type.
Excerpt: Complaints records are deficient in that they do not include the findings of the investigation and follow-up.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Complaints about sub-potent or super-potent products were not adequately tested for potency, evidencing gaps in complaint management.
Excerpt: Complaints involving drug product efficacy were not tested for assay as part of your investigation.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Dr. Reddy's Laboratories Limited		 12 Dec 2025 Normal Justification: The observation states market complaints were mishandled, linking to complaint management processes.
Excerpt: You unsubstantiated the Market Complaints for the (b)(4) batches that were not part of this campaign.
View Details
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed
Lupin Limited		 21 Nov 2025 Normal Justification: The observation highlights significant shortcomings in handling complaints, crucial for identifying potential defects or safety issues.
Excerpt: Your Quality Unit failed to thoroughly investigate adverse drug events (ADE) and market complaints relating to Lack of Effect (LOE).
View Details

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