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Manufacturers' Association Conference 2026
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Sub System /
Complaint Management
Complaint Management
View Detailed Analysis

Analytics Overview

84
Form 483s Issued
16
483s converted to WL
104
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
06 Nov 2025
Fresenius Kabi Compounding, LLC
Drugs
31 Oct 2025
Lonza Guangzhou Pharmaceutical Ltd.
Drugs
14 Oct 2025
UBI Pharma Inc.
Drugs

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
TITLE/ COMPANY Issue Date Status 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any
Fresenius Kabi Compounding, LLC
06 Nov 2025 Normal Justification: Complaint Management processes failed to capture and resolve customer complaints related to defective IV bags.
Excerpt: Your firm has received customer complaints for leaking IV bags and in some cases not identified the specific root cause.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Lonza Guangzhou Pharmaceutical Ltd.
31 Oct 2025 Normal Justification: The observation highlights inadequate complaint handling, pointing to flaws in the Complaint Management process requiring rectification.
Excerpt: The quality unit failed to provide adequate complaint investigations...failed to evaluate reserve/retention samples...
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
UBI Pharma Inc.
14 Oct 2025 Normal Justification: Complaint Management is directly impacted by failure to investigate and address complaints as stipulated in the expired QA.
Excerpt: Your customer, decided not to investigate and file FAR. According to your (expired) QA, you are responsible for complaint investigation.
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.

Complaint Management

Overview

84
Form 483s Issued
16
483s converted to WL
104
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
06 Nov 2025
Fresenius Kabi Compounding, LLC
Drugs
31 Oct 2025
Lonza Guangzhou Pharmaceutical Ltd.
Drugs
14 Oct 2025
UBI Pharma Inc.
Drugs

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
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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any
Fresenius Kabi Compounding, LLC
06 Nov 2025 Normal Justification: Complaint Management processes failed to capture and resolve customer complaints related to defective IV bags.
Excerpt: Your firm has received customer complaints for leaking IV bags and in some cases not identified the specific root cause.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Lonza Guangzhou Pharmaceutical Ltd.
31 Oct 2025 Normal Justification: The observation highlights inadequate complaint handling, pointing to flaws in the Complaint Management process requiring rectification.
Excerpt: The quality unit failed to provide adequate complaint investigations...failed to evaluate reserve/retention samples...
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
UBI Pharma Inc.
14 Oct 2025 Normal Justification: Complaint Management is directly impacted by failure to investigate and address complaints as stipulated in the expired QA.
Excerpt: Your customer, decided not to investigate and file FAR. According to your (expired) QA, you are responsible for complaint investigation.
View Details

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