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Sub System /
Process Monitoring
Process Monitoring
View Detailed Analysis

Analytics Overview

46
Form 483s Issued
4
483s converted to WL
51
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483
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

Top Investigators

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

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation notes lapses in personnel monitoring, critical to controlling contamination during aseptic processes.
Excerpt: No personnel monitoring is performed upon re-entry from Grade A to Grade B following such interventions.
View Details
Batch production and control records do not include complete information relating to the production and control
Gland Chemicals Private Limited		 27 Nov 2025 Normal Justification: Process monitoring lapses caused exceeding validated frequency of interventions, impacting process control.
Excerpt: Corrective intervention frequency in media fill exceeded validated maximum.
View 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

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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

46
Form 483s Issued
4
483s converted to WL
51
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483
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

Top FDA Investigators

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

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation notes lapses in personnel monitoring, critical to controlling contamination during aseptic processes.
Excerpt: No personnel monitoring is performed upon re-entry from Grade A to Grade B following such interventions.
View Details
Batch production and control records do not include complete information relating to the production and control
Gland Chemicals Private Limited		 27 Nov 2025 Normal Justification: Process monitoring lapses caused exceeding validated frequency of interventions, impacting process control.
Excerpt: Corrective intervention frequency in media fill exceeded validated maximum.
View 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

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