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Sub System /
Process Monitoring
Process Monitoring
View Detailed Analysis

Analytics Overview

43
Form 483s Issued
4
483s converted to WL
54
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
21 Nov 2025
Shilpa Medicare Limited
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483
14 Oct 2025
UBI Pharma Inc.
Drugs
View Form 483
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
David Carlson
7
0
Kiya Hamilton
7
0
Christy Osgood
7
0
LaiMing Lee
7
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Shilpa Medicare Limited		 21 Nov 2025 Normal Justification: Observation highlights gaps in monitoring processes affecting process documentation quality.
Excerpt: Interventions which occur during commercial manufacturing are not tracked or trended per container size.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed
Empower Clinic Services, L.L.C. dba Empower Pharma		 14 Nov 2025 Normal Justification: Process Monitoring ensures compliance with PPE standards during hazardous drug handling, reducing contamination and exposure risks.
Excerpt: A (b) (4) respirator and a (b) (4) gown are only worn during Formulation but not during (b) (4).
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and/or followed.
UBI Pharma Inc.		 14 Oct 2025 Normal Justification: Process monitoring is critical as it ensures procedures are followed correctly, preventing lapses in sterility protocols.
Excerpt: Video recorded of the air flow studies performed were deficient in the following ways.
View Details
Control procedures are not established which monitor the output and validate the performance
UBI Pharma Inc.		 14 Oct 2025 Normal Justification: Issue arises from inadequate monitoring and validation of manufacturing processes causing quality variability.
Excerpt: Control procedures are not established which monitor the output and validate the performance of those manufacturing processes.
View Details
In Study RGB-14-001, one male patient of 49 years of age experienced clinically significant liver enzyme shifts
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: Monitoring of clinical trial processes ensures data integrity and timely decision-making based on laboratory results.
Excerpt: Repeated elevations in liver enzymes occurred, indicating a lack of ongoing oversight in process monitoring.
View Details

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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

43
Form 483s Issued
4
483s converted to WL
54
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
21 Nov 2025
Shilpa Medicare Limited
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483
14 Oct 2025
UBI Pharma Inc.
Drugs
View Form 483
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
David Carlson
7
0
Kiya Hamilton
7
0
Christy Osgood
7
0
LaiMing Lee
7
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Shilpa Medicare Limited		 21 Nov 2025 Normal Justification: Observation highlights gaps in monitoring processes affecting process documentation quality.
Excerpt: Interventions which occur during commercial manufacturing are not tracked or trended per container size.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed
Empower Clinic Services, L.L.C. dba Empower Pharma		 14 Nov 2025 Normal Justification: Process Monitoring ensures compliance with PPE standards during hazardous drug handling, reducing contamination and exposure risks.
Excerpt: A (b) (4) respirator and a (b) (4) gown are only worn during Formulation but not during (b) (4).
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and/or followed.
UBI Pharma Inc.		 14 Oct 2025 Normal Justification: Process monitoring is critical as it ensures procedures are followed correctly, preventing lapses in sterility protocols.
Excerpt: Video recorded of the air flow studies performed were deficient in the following ways.
View Details
Control procedures are not established which monitor the output and validate the performance
UBI Pharma Inc.		 14 Oct 2025 Normal Justification: Issue arises from inadequate monitoring and validation of manufacturing processes causing quality variability.
Excerpt: Control procedures are not established which monitor the output and validate the performance of those manufacturing processes.
View Details
In Study RGB-14-001, one male patient of 49 years of age experienced clinically significant liver enzyme shifts
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: Monitoring of clinical trial processes ensures data integrity and timely decision-making based on laboratory results.
Excerpt: Repeated elevations in liver enzymes occurred, indicating a lack of ongoing oversight in process monitoring.
View Details

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