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Sub System /
Process Monitoring
Process Monitoring
View Detailed Analysis

Analytics Overview

39
Form 483s Issued
4
483s converted to WL
43
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
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
16 Sep 2025
Fareva Amboise
Drugs
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Justin A Boyd
4
1
Anastasia M Shields
3
1
Joohi Castelvetere
2
0
Brandy N Lepage
2
0
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products
Immacule Lifesciences Private Limited
18 Sep 2025 Normal Justification: Without adequate process monitoring and trend analysis of operator interventions, critical insights into aseptic process effectiveness are lost.
Excerpt: The lack of trending for the (b)(4) interventions in TS products does not drive corrective and preventive actions.
View Details
Appropriate controls are not exercised over computers or related systems
Fareva Amboise
16 Sep 2025 Normal Justification: Observation highlights gaps in real-time monitoring of process controls, impacting product quality data integrity.
Excerpt: Non-conforming result was not recorded; later retest was performed after moving the NVPC.
View 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

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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.

Process Monitoring

Overview

39
Form 483s Issued
4
483s converted to WL
43
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
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
16 Sep 2025
Fareva Amboise
Drugs
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Justin A Boyd
4
1
Anastasia M Shields
3
1
Joohi Castelvetere
2
0
Brandy N Lepage
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products
Immacule Lifesciences Private Limited
18 Sep 2025 Normal Justification: Without adequate process monitoring and trend analysis of operator interventions, critical insights into aseptic process effectiveness are lost.
Excerpt: The lack of trending for the (b)(4) interventions in TS products does not drive corrective and preventive actions.
View Details
Appropriate controls are not exercised over computers or related systems
Fareva Amboise
16 Sep 2025 Normal Justification: Observation highlights gaps in real-time monitoring of process controls, impacting product quality data integrity.
Excerpt: Non-conforming result was not recorded; later retest was performed after moving the NVPC.
View 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

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