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Sub System /
Training Management
Training Management
View Detailed Analysis

Analytics Overview

129
Form 483s Issued
28
483s converted to WL
186
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
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
12 Dec 2025
Dr. Reddy's Laboratories Limited
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
Sena G Dissmeyer
10
0
José E Melendez
9
0
Pratik S Upadhyay
9
3
Logan T Williams
8
5
Saleem A Akhtar
8
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Training Management is compromised since inspectors were inadequately qualified.
Excerpt: Inspectors are qualified despite not meeting the acceptance criteria established in your written procedures.
View Details
GMP training is not conducted on a continuing basis with sufficient frequency
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Training Management is directly linked to the observed issue of incomplete employee training as per CGMP requirements.
Excerpt: Review of your training program revealed significant deficiencies in training completion compliance.
View Details
Employees are not given training in the particular operations they perform as part of their function.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: The observation highlights that inspectors lacked the necessary training and tools to perform their roles adequately, aligning directly with training management deficiencies.
Excerpt: The firm does not have physical destructive testing defect kits for difficult to inspect sterile products...
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination
Dr. Reddy's Laboratories Limited		 12 Dec 2025 Normal Justification: Deficiencies in training impact the qualification of visual inspectors, leading to quality defects and market complaints.
Excerpt: There is no information about the type of defects and the number of defective tables in the test kit.
View Details
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: The issue directly relates to inadequate training of operators, impacting product inspection efficacy.
Excerpt: Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education, training and experience required.
View Details

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Training Management

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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Training Management

Overview

129
Form 483s Issued
28
483s converted to WL
186
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
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
12 Dec 2025
Dr. Reddy's Laboratories Limited
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
Sena G Dissmeyer
10
0
José E Melendez
9
0
Pratik S Upadhyay
9
3
Logan T Williams
8
5
Saleem A Akhtar
8
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Training Management is compromised since inspectors were inadequately qualified.
Excerpt: Inspectors are qualified despite not meeting the acceptance criteria established in your written procedures.
View Details
GMP training is not conducted on a continuing basis with sufficient frequency
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Training Management is directly linked to the observed issue of incomplete employee training as per CGMP requirements.
Excerpt: Review of your training program revealed significant deficiencies in training completion compliance.
View Details
Employees are not given training in the particular operations they perform as part of their function.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: The observation highlights that inspectors lacked the necessary training and tools to perform their roles adequately, aligning directly with training management deficiencies.
Excerpt: The firm does not have physical destructive testing defect kits for difficult to inspect sterile products...
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination
Dr. Reddy's Laboratories Limited		 12 Dec 2025 Normal Justification: Deficiencies in training impact the qualification of visual inspectors, leading to quality defects and market complaints.
Excerpt: There is no information about the type of defects and the number of defective tables in the test kit.
View Details
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: The issue directly relates to inadequate training of operators, impacting product inspection efficacy.
Excerpt: Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education, training and experience required.
View Details

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