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Sub System /
Field Alert Report
Field Alert Report
View Detailed Analysis

Analytics Overview

6
Form 483s Issued
2
483s converted to WL
6
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
19 Nov 2024
Janssen Vaccines Corporation
Drugs
View Form 483
15 Dec 2023
Sun Pharmaceutical Industries Limited
Drugs
View Form 483
View Warning Letter
27 Oct 2023
Dr. Reddy's Laboratories Ltd.
Drugs
View Form 483
15 Sep 2023
Samsung Bioepis Co., Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
2
1
Saleem A Akhtar
2
1
Jose E Melendez
1
1
Scott N Lim
1
0
Yiwei Li
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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
Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product
Sun Pharmaceutical Industries Limited		 15 Dec 2023 Normal Justification: The issue specifically relates to the failure to submit necessary Field Alert Reports as mandated by both FDA regulations and internal SOPs, evidencing a direct linkage to the Field Alert Report process type.
Excerpt: "An (b) (4) -Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product."
View Details
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 Ltd.		 27 Oct 2023 Normal Justification: The delay in filing the Field Alert Reports and improper closure without proper evaluation highlights a critical gap in the Field Alert Report handling process.
Excerpt: The firm initiated a separate OOS investigation and filed a Field Alert on 25-Jan-2021 to the agency.
View Details
Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required
Samsung Bioepis Co., Ltd.		 15 Sep 2023 Normal Justification: The observation pertains to the delay in submission of post marketing 15-day alert reports, directly tying it to the Field Alert Report process type.
Excerpt: Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required.
View Details

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Uncover Trends: FDA Investigator profiles & Observations.
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Go back

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
Share

Field Alert Report

Overview

6
Form 483s Issued
2
483s converted to WL
6
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
19 Nov 2024
Janssen Vaccines Corporation
Drugs
View Form 483
15 Dec 2023
Sun Pharmaceutical Industries Limited
Drugs
View Form 483
View Warning Letter
27 Oct 2023
Dr. Reddy's Laboratories Ltd.
Drugs
View Form 483
15 Sep 2023
Samsung Bioepis Co., Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
2
1
Saleem A Akhtar
2
1
Jose E Melendez
1
1
Scott N Lim
1
0
Yiwei Li
1
0

Key Observations

TITLE/ COMPANY Issue Date Status 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
Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product
Sun Pharmaceutical Industries Limited		 15 Dec 2023 Normal Justification: The issue specifically relates to the failure to submit necessary Field Alert Reports as mandated by both FDA regulations and internal SOPs, evidencing a direct linkage to the Field Alert Report process type.
Excerpt: "An (b) (4) -Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product."
View Details
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 Ltd.		 27 Oct 2023 Normal Justification: The delay in filing the Field Alert Reports and improper closure without proper evaluation highlights a critical gap in the Field Alert Report handling process.
Excerpt: The firm initiated a separate OOS investigation and filed a Field Alert on 25-Jan-2021 to the agency.
View Details
Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required
Samsung Bioepis Co., Ltd.		 15 Sep 2023 Normal Justification: The observation pertains to the delay in submission of post marketing 15-day alert reports, directly tying it to the Field Alert Report process type.
Excerpt: Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required.
View Details

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