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Software Lifecycle Management
Software Lifecycle Management
View Detailed Analysis

Analytics Overview

1
Form 483s Issued
1
483s converted to WL
1
Total Observation
Form 483s Issued
+74 from last period

Analytics Overview

Form 483 Conversion Rate by Year
483s Not Converted to WL
483s Converted to WL
1.01.00.80.80.60.60.40.40.20.20.00.020232023
Form 483s Issued (Yearly)
1.01.00.80.80.60.60.40.40.20.20.00.020232023

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
10 Feb 2023
Nephron Sterile Compounding Center LLC
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Clifton L Randell
1
1
Jamie L Port
1
1
June P Page
1
1
Mary-Jeanet Mcgarry
1
1
Melanie M Walker
1
1
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Nephron Sterile Compounding Center LLC
10 Feb 2023 Normal Justification: Software Lifecycle Management is necessary to ensure any software used in the manufacturing processes is validated and maintained over time, preventing potential compliance issues.
Excerpt: Ensure software validations and process validations are performed.
View Details

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Software Lifecycle 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

Software Lifecycle Management

Overview

1
Form 483s Issued
1
483s converted to WL
1
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
10 Feb 2023
Nephron Sterile Compounding Center LLC
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Clifton L Randell
1
1
Jamie L Port
1
1
June P Page
1
1
Mary-Jeanet Mcgarry
1
1
Melanie M Walker
1
1

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.
Nephron Sterile Compounding Center LLC
10 Feb 2023 Normal Justification: Software Lifecycle Management is necessary to ensure any software used in the manufacturing processes is validated and maintained over time, preventing potential compliance issues.
Excerpt: Ensure software validations and process validations are performed.
View Details

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