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Sub System /
Training Management
Training Management
View Detailed Analysis

Analytics Overview

113
Form 483s Issued
28
483s converted to WL
168
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 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
11
4
Sena G Dissmeyer
10
0
Pratik S Upadhyay
10
3
Saleem A Akhtar
8
2
Arsen Karapetyan
8
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: The deficit in employee training indicates gaps in Training Management, necessary for ensuring operational compliance.
Excerpt: Employee training and qualifications for cGMP manufacturing.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Training modules were created but failed to iterate improvements into SOPs affecting future operations.
Excerpt: Training module was created... failed to implement the improved setup instruction.
View Details
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Training Management is impacted because the observation cites inadequate documentation of technician training and experience, which is crucial for sterile operations.
Excerpt: Your firm failed to provide documentation of training or relevant experience for all your technicians involved in sterile processing operations.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Training management is critical, as inadequate training leads directly to unqualified personnel and quality risks.
Excerpt: The employees performing visual inspection on sterile drug products were only qualified according to the previous procedure.
View Details
Employees engaged in the manufacture, processing and packing of a drug product lack the training required to perform their assigned functions.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: The observation highlights deficiencies in training for visual inspection, necessitating a focus on Training Management to address these gaps.
Excerpt: Employees engaged in the manufacture, processing and packing of a drug product lack the training required to perform their assigned functions.
View Details

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Go back

Training Management

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Training Management

Overview

113
Form 483s Issued
28
483s converted to WL
168
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
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
11
4
Sena G Dissmeyer
10
0
Pratik S Upadhyay
10
3
Saleem A Akhtar
8
2
Arsen Karapetyan
8
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: The deficit in employee training indicates gaps in Training Management, necessary for ensuring operational compliance.
Excerpt: Employee training and qualifications for cGMP manufacturing.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Training modules were created but failed to iterate improvements into SOPs affecting future operations.
Excerpt: Training module was created... failed to implement the improved setup instruction.
View Details
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Training Management is impacted because the observation cites inadequate documentation of technician training and experience, which is crucial for sterile operations.
Excerpt: Your firm failed to provide documentation of training or relevant experience for all your technicians involved in sterile processing operations.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Training management is critical, as inadequate training leads directly to unqualified personnel and quality risks.
Excerpt: The employees performing visual inspection on sterile drug products were only qualified according to the previous procedure.
View Details
Employees engaged in the manufacture, processing and packing of a drug product lack the training required to perform their assigned functions.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: The observation highlights deficiencies in training for visual inspection, necessitating a focus on Training Management to address these gaps.
Excerpt: Employees engaged in the manufacture, processing and packing of a drug product lack the training required to perform their assigned functions.
View Details

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