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Sub System /
Process Monitoring
Process Monitoring
View Detailed Analysis

Analytics Overview

34
Form 483s Issued
4
483s converted to WL
37
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 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
04 Jul 2025
Alvotech HF
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Justin A Boyd
3
1
Anastasia M Shields
3
1
Brandy N Lepage
2
0
Edmund F Mrak
2
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate aseptic techniques during aseptic filling setup for Batch No.
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: These monitoring lapses during fill setup negatively impacted sterility assurance, requiring stricter process oversight.
Excerpt: Smoke study videos also show the operator blocking first air during setup.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: Inadequate smoke studies indicate poor process monitoring, which is critical for maintaining sterility.
Excerpt: Turbulent airflow was observed... you did not perform dynamic smoke studies to assess impact.
View Details
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
Sumitomo Pharma Co., Ltd.		 07 Aug 2025 Normal Justification: The need for process monitoring is evident due to the absence of strategy evaluation for microbial control.
Excerpt: Your system has not been evaluated for the absence of objectionable microorganisms.
View Details
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: The observation directly highlights the absence of in-process controls, a fundamental aspect of Process Monitoring.
Excerpt: Your firm does not have validated methods or procedures for assessing the essential physical characteristics of work-in-progress (WIP) pellets.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Alvotech HF		 04 Jul 2025 Normal Justification: Process monitoring is implicated due to the lack of assurance in simulating critical interventions during media fills.
Excerpt: No evaluation was conducted to verify that each certified operator had performed all routine and corrective critical interventions.
View Details

Prepare Better for FDA Audits with FDA Tracker

Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
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Process Monitoring

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

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Process Monitoring

Overview

34
Form 483s Issued
4
483s converted to WL
37
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
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
04 Jul 2025
Alvotech HF
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Justin A Boyd
3
1
Anastasia M Shields
3
1
Brandy N Lepage
2
0
Edmund F Mrak
2
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate aseptic techniques during aseptic filling setup for Batch No.
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: These monitoring lapses during fill setup negatively impacted sterility assurance, requiring stricter process oversight.
Excerpt: Smoke study videos also show the operator blocking first air during setup.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: Inadequate smoke studies indicate poor process monitoring, which is critical for maintaining sterility.
Excerpt: Turbulent airflow was observed... you did not perform dynamic smoke studies to assess impact.
View Details
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
Sumitomo Pharma Co., Ltd.		 07 Aug 2025 Normal Justification: The need for process monitoring is evident due to the absence of strategy evaluation for microbial control.
Excerpt: Your system has not been evaluated for the absence of objectionable microorganisms.
View Details
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: The observation directly highlights the absence of in-process controls, a fundamental aspect of Process Monitoring.
Excerpt: Your firm does not have validated methods or procedures for assessing the essential physical characteristics of work-in-progress (WIP) pellets.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Alvotech HF		 04 Jul 2025 Normal Justification: Process monitoring is implicated due to the lack of assurance in simulating critical interventions during media fills.
Excerpt: No evaluation was conducted to verify that each certified operator had performed all routine and corrective critical interventions.
View Details

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