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Sub System /
Complaint Management
Complaint Management
View Detailed Analysis

Analytics Overview

70
Form 483s Issued
16
483s converted to WL
87
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
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
30 May 2025
Capricor, Inc.
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Taichun Qin
6
3
Jose E Melendez
6
3
Pratik S Upadhyay
6
4
Crystal Monroy
4
0
Arsen Karapetyan
4
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Written records of investigation of a drug complaint do not include the follow-up.
Cohance Lifesciences Limited		 12 Aug 2025 Normal Justification: The observation directly addresses the processes of managing customer complaints, specifically noting deficiencies in follow-up and documentation.
Excerpt: Written records of investigation of a drug complaint do not include the follow-up. Specifically,...
View Details
Complaint records are deficient in that they do not include the findings of the investigation and follow-up
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Complaint Management is directly involved as the investigations were found lacking due to missing sample analyses.
Excerpt: Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
View Details
There is a failure to evaluate and investigate any unexplained discrepancy whether or not the batch has been already distributed
Not available		 01 Aug 2025 Normal Justification: Inadequate handling and resolution of product complaints is directly tied to flaws in the 'Complaint Management' process.
Excerpt: Product defect complaints related to Batch #1225 were logged without proper investigation follow-up...
View Details
Procedures applicable to the quality control unit are not in writing
Capricor, Inc.		 30 May 2025 Normal Justification: Complaint Management critically involves structured procedures which are missing, weakening response to quality issues.
Excerpt: Procedures for the receiving, evaluating, and documenting complaints related to (b)(4) have not been established.
View Details
A Field Alert Report was not submitted within three working days of receipt
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Complaints triggered the field alert; thus, improving Complaint Management is crucial to timely FAR submission.
Excerpt: Your firm received similar complaints for distributed drug product Solution USP Lot Number.
View Details

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Go back

Complaint 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

Complaint Management

Overview

70
Form 483s Issued
16
483s converted to WL
87
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
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
30 May 2025
Capricor, Inc.
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Taichun Qin
6
3
Jose E Melendez
6
3
Pratik S Upadhyay
6
4
Crystal Monroy
4
0
Arsen Karapetyan
4
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Written records of investigation of a drug complaint do not include the follow-up.
Cohance Lifesciences Limited		 12 Aug 2025 Normal Justification: The observation directly addresses the processes of managing customer complaints, specifically noting deficiencies in follow-up and documentation.
Excerpt: Written records of investigation of a drug complaint do not include the follow-up. Specifically,...
View Details
Complaint records are deficient in that they do not include the findings of the investigation and follow-up
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Complaint Management is directly involved as the investigations were found lacking due to missing sample analyses.
Excerpt: Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
View Details
There is a failure to evaluate and investigate any unexplained discrepancy whether or not the batch has been already distributed
Not available		 01 Aug 2025 Normal Justification: Inadequate handling and resolution of product complaints is directly tied to flaws in the 'Complaint Management' process.
Excerpt: Product defect complaints related to Batch #1225 were logged without proper investigation follow-up...
View Details
Procedures applicable to the quality control unit are not in writing
Capricor, Inc.		 30 May 2025 Normal Justification: Complaint Management critically involves structured procedures which are missing, weakening response to quality issues.
Excerpt: Procedures for the receiving, evaluating, and documenting complaints related to (b)(4) have not been established.
View Details
A Field Alert Report was not submitted within three working days of receipt
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Complaints triggered the field alert; thus, improving Complaint Management is crucial to timely FAR submission.
Excerpt: Your firm received similar complaints for distributed drug product Solution USP Lot Number.
View Details

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