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Field Alert Report
Field Alert Report
View Detailed Analysis

Analytics Overview

8
Form 483s Issued
2
483s converted to WL
9
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
10 Apr 2025
Aurolige Pharma LLC
Drugs
19 Nov 2024
Janssen Vaccines Corporation
Drugs
12 Mar 2024
GlaxoSmithKline Biologicals
Drugs
15 Dec 2023
Sun Pharmaceutical Industries Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
2
1
Saleem A Akhtar
2
1
Guerlain Ulysse
2
0
Laurimer Kuilan-Torres
1
0
Rajiv R Srivastava
1
0
TITLE/ COMPANY Issue Date Status 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
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
A Field Alert Report was not submitted within three working days of receipt
Aurolige Pharma LLC
10 Apr 2025 Normal Justification: The issue directly relates to the Field Alert Report process as the observation cites failure to submit FAR timely.
Excerpt: Your firm failed to submit a Field Alert Report (FAR) to the agency within three (3) working days.
View Details
Responsibilities and procedures for quality units are not in writing and/or followed to ensure the FARS (BPDR) are submitted
Janssen Vaccines Corporation
19 Nov 2024 Normal Justification: The issue involves failure to submit FARs despite multiple complaints of the same defect. Proper execution of Field Alert Report procedures ensures compliance with FDA reporting regulations.
Excerpt: You failed to follow your procedure, TV-WI-21853 Version 29.0 Product Quality Complaint Investigation (Effective date 5/25/2024) Section 7.11.1.2 that sets the requirement for FAR (BPDR).
View Details
Reserve samples from representative sample lots or batches of drug products
GlaxoSmithKline Biologicals
12 Mar 2024 Normal Justification: Delayed reporting of adverse drug experiences relates specifically to the Field Alert Report process.
Excerpt: Eighty-four (84) 15-Day Alert reports were reported late (after 15 days) for Shingrix Vaccine.
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.

Written By
Vivek Gera
Reading Time
8
Minutes

Field Alert Report

Overview

8
Form 483s Issued
2
483s converted to WL
9
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
12 Aug 2025
Cohance Lifesciences Limited
Drugs
10 Apr 2025
Aurolige Pharma LLC
Drugs
19 Nov 2024
Janssen Vaccines Corporation
Drugs
12 Mar 2024
GlaxoSmithKline Biologicals
Drugs
15 Dec 2023
Sun Pharmaceutical Industries Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
2
1
Saleem A Akhtar
2
1
Guerlain Ulysse
2
0
Laurimer Kuilan-Torres
1
0
Rajiv R Srivastava
1
0

Key Observations

TITLE/ COMPANY Issue Date Status 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
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
A Field Alert Report was not submitted within three working days of receipt
Aurolige Pharma LLC
10 Apr 2025 Normal Justification: The issue directly relates to the Field Alert Report process as the observation cites failure to submit FAR timely.
Excerpt: Your firm failed to submit a Field Alert Report (FAR) to the agency within three (3) working days.
View Details
Responsibilities and procedures for quality units are not in writing and/or followed to ensure the FARS (BPDR) are submitted
Janssen Vaccines Corporation
19 Nov 2024 Normal Justification: The issue involves failure to submit FARs despite multiple complaints of the same defect. Proper execution of Field Alert Report procedures ensures compliance with FDA reporting regulations.
Excerpt: You failed to follow your procedure, TV-WI-21853 Version 29.0 Product Quality Complaint Investigation (Effective date 5/25/2024) Section 7.11.1.2 that sets the requirement for FAR (BPDR).
View Details
Reserve samples from representative sample lots or batches of drug products
GlaxoSmithKline Biologicals
12 Mar 2024 Normal Justification: Delayed reporting of adverse drug experiences relates specifically to the Field Alert Report process.
Excerpt: Eighty-four (84) 15-Day Alert reports were reported late (after 15 days) for Shingrix Vaccine.
View Details

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