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Sub System /
Complaint Management
Complaint Management
View Detailed Analysis

Analytics Overview

64
Form 483s Issued
14
483s converted to WL
80
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
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483
17 Feb 2025
Piramal Pharma Limited
Drugs
View Form 483
22 Nov 2024
Samsung Bioepis Co. Ltd.
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
6
4
Taichun Qin
5
2
Saleem A Akhtar
4
2
Justin A Boyd
4
4
Arsen Karapetyan
4
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Procedures for corrective and preventive action have not been adequately established.
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Complaint management inadequacies allow defective products to persist in the market, connected to CAPA lapses.
Excerpt: Over a hundred (100) complaints for malfunction indicate poor complaint resolution.
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
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.
Wells Pharma of Houston LLC		 28 Mar 2025 Normal Justification: The issue stems from a failure in following the adverse event management process as defined in the SOP.
Excerpt: Your firm failed to follow your adverse event procedures, SOP HOU- QA-041, Pharmacovigilance Procedure for Adverse Events.
View Details
Written records of investigation of an API complaint do not include adequate follow-up
Piramal Pharma Limited		 17 Feb 2025 Normal Justification: This issue pertains to 'Complaint Management' as it directly involves deficiencies in handling customer complaints, including sample testing obligations.
Excerpt: Customer Complaint CC-22-06 was initiated on May 21, 2022, due to foreign particles... However, there was no documented attempt to retrieve and test the customer complaint sample.
View Details
Procedures describing the handling of written and oral complaints related to drug products are not written and/or followed.
Samsung Bioepis Co. Ltd.		 22 Nov 2024 Normal Justification: The entire observation revolves around the shortcomings in complaint filing, assessment, categorization, and follow-up processes.
Excerpt: Your complaint handling procedure, SOP-GxP-CML-00944 Version 13.0 Product Quality Complaints Management does not have a timeline for initial assessment for market complaints.
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

64
Form 483s Issued
14
483s converted to WL
80
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
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483
17 Feb 2025
Piramal Pharma Limited
Drugs
View Form 483
22 Nov 2024
Samsung Bioepis Co. Ltd.
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
6
4
Taichun Qin
5
2
Saleem A Akhtar
4
2
Justin A Boyd
4
4
Arsen Karapetyan
4
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures for corrective and preventive action have not been adequately established.
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Complaint management inadequacies allow defective products to persist in the market, connected to CAPA lapses.
Excerpt: Over a hundred (100) complaints for malfunction indicate poor complaint resolution.
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
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.
Wells Pharma of Houston LLC		 28 Mar 2025 Normal Justification: The issue stems from a failure in following the adverse event management process as defined in the SOP.
Excerpt: Your firm failed to follow your adverse event procedures, SOP HOU- QA-041, Pharmacovigilance Procedure for Adverse Events.
View Details
Written records of investigation of an API complaint do not include adequate follow-up
Piramal Pharma Limited		 17 Feb 2025 Normal Justification: This issue pertains to 'Complaint Management' as it directly involves deficiencies in handling customer complaints, including sample testing obligations.
Excerpt: Customer Complaint CC-22-06 was initiated on May 21, 2022, due to foreign particles... However, there was no documented attempt to retrieve and test the customer complaint sample.
View Details
Procedures describing the handling of written and oral complaints related to drug products are not written and/or followed.
Samsung Bioepis Co. Ltd.		 22 Nov 2024 Normal Justification: The entire observation revolves around the shortcomings in complaint filing, assessment, categorization, and follow-up processes.
Excerpt: Your complaint handling procedure, SOP-GxP-CML-00944 Version 13.0 Product Quality Complaints Management does not have a timeline for initial assessment for market complaints.
View Details

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