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Sub System /
Process Monitoring
Process Monitoring
View Detailed Analysis

Analytics Overview

52
Form 483s Issued
4
483s converted to WL
59
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
05 May 2026
Zydus Lifesciences Limited
Drugs
20 Feb 2026
Maiva Pharma Private Limited
Drugs
27 Nov 2025
Gland Chemicals Private Limited
Drugs
21 Nov 2025
Shilpa Medicare Limited
Drugs
17 Nov 2025
Americord Registry LLC
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Christy Osgood
7
0
David Carlson
7
0
Kiya Hamilton
7
0
LaiMing Lee
7
0
TITLE/ COMPANY Issue Date Status Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Zydus Lifesciences Limited
05 May 2026 Normal Justification: Monitoring deviations in air velocity ensures environmental conditions remain within control limits.
Excerpt: Large changes in the working height air velocities from initial and requalification studies were not investigated.
View 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
Records did not identify the person performing the work
Americord Registry LLC
17 Nov 2025 Normal Justification: Process Monitoring is key as tracking sterilization cycles and UCB status extends to process oversight and control.
Excerpt: There are no utensil sterilization records documented including cycle temperature and duration.
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.

Process Monitoring

Overview

52
Form 483s Issued
4
483s converted to WL
59
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
05 May 2026
Zydus Lifesciences Limited
Drugs
20 Feb 2026
Maiva Pharma Private Limited
Drugs
27 Nov 2025
Gland Chemicals Private Limited
Drugs
21 Nov 2025
Shilpa Medicare Limited
Drugs
17 Nov 2025
Americord Registry LLC
Drugs

Top FDA Investigators

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

Key Observations

TITLE/ COMPANY Issue Date Status Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Zydus Lifesciences Limited
05 May 2026 Normal Justification: Monitoring deviations in air velocity ensures environmental conditions remain within control limits.
Excerpt: Large changes in the working height air velocities from initial and requalification studies were not investigated.
View 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
Records did not identify the person performing the work
Americord Registry LLC
17 Nov 2025 Normal Justification: Process Monitoring is key as tracking sterilization cycles and UCB status extends to process oversight and control.
Excerpt: There are no utensil sterilization records documented including cycle temperature and duration.
View Details

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Related Resources

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