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Pharmaceutical Quality Summit 2026
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Sub System /
Field Alert Report
Field Alert Report
View Detailed Analysis

Analytics Overview

11
Form 483s Issued
2
483s converted to WL
12
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
21 Nov 2025
Lupin Limited
Drugs
14 Oct 2025
UBI Pharma Inc.
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs
10 Apr 2025
Aurolige Pharma LLC
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
3
3
Guerlain Ulysse
2
0
Pratik S Upadhyay
2
1
Lisa L Flores
1
0
Laurimer Kuilan-Torres
1
0
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: A critical process failure didn't prompt Field Alert initiation, likely due to SOP ambiguities and awareness gaps.
Excerpt: No Field Alert was initiated for this media fill failure.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Lupin Limited
21 Nov 2025 Normal Justification: Negligence in Field Alert Reporting post-recall led to critical non-compliance with FDA regulations.
Excerpt: Despite the recall action, no Field Alert Report (FAR) was submitted to the FDA as required.
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: Field Alert Reports are essential in signaling potential significant quality issues to the FDA, which were missed here.
Excerpt: Your initial QA did not have a provision for timely submission of Field Alert Reports.
View Details
Written records of investigation of a drug complaint do not include the follow-up.
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: The absence of communication and potential failure to file required Field Alert Reports indicates process lapses.
Excerpt: SOP QA084-02, Field Alert Report... However, there is no documented explanation...
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: Directly linked to the unlogged complaints in Field Alert Report Log, violating SOP requirements.
Excerpt: Complaint investigations that are involved with field alert reporting activities are not logged into the Field Alert Report Log.
View Details

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Field Alert Report

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Field Alert Report

Overview

11
Form 483s Issued
2
483s converted to WL
12
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
21 Nov 2025
Lupin Limited
Drugs
14 Oct 2025
UBI Pharma Inc.
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs
10 Apr 2025
Aurolige Pharma LLC
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
3
3
Guerlain Ulysse
2
0
Pratik S Upadhyay
2
1
Lisa L Flores
1
0
Laurimer Kuilan-Torres
1
0

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: A critical process failure didn't prompt Field Alert initiation, likely due to SOP ambiguities and awareness gaps.
Excerpt: No Field Alert was initiated for this media fill failure.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Lupin Limited
21 Nov 2025 Normal Justification: Negligence in Field Alert Reporting post-recall led to critical non-compliance with FDA regulations.
Excerpt: Despite the recall action, no Field Alert Report (FAR) was submitted to the FDA as required.
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: Field Alert Reports are essential in signaling potential significant quality issues to the FDA, which were missed here.
Excerpt: Your initial QA did not have a provision for timely submission of Field Alert Reports.
View Details
Written records of investigation of a drug complaint do not include the follow-up.
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: The absence of communication and potential failure to file required Field Alert Reports indicates process lapses.
Excerpt: SOP QA084-02, Field Alert Report... However, there is no documented explanation...
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: Directly linked to the unlogged complaints in Field Alert Report Log, violating SOP requirements.
Excerpt: Complaint investigations that are involved with field alert reporting activities are not logged into the Field Alert Report Log.
View Details

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