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Sub System /
Software Lifecycle Management
Software Lifecycle Management
View Detailed Analysis

Analytics Overview

10
Form 483s Issued
1
483s converted to WL
10
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
09 Feb 2026
Collaborative Care Diagnostics, LLC.
Drugs
29 Aug 2025
XL PRECISION TECHNOLOGIES LTD
Drugs
11 Mar 2025
Fujifilm Diosynth Biotechnologies Texas, LLC
Drugs
17 Jan 2025
Philips Medical Systems Nederland B.V.
Drugs
06 Nov 2024
ARUP Laboratories, Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kathleen B. Swat
3
0
Nadia R Barreda
2
0
Joshua J Silvestri
2
0
Janet Pulver
2
0
Dennis R Hock
1
0
TITLE/ COMPANY Issue Date Status Details
One or more processes for risk management in product realization have not been adequately documented.
Collaborative Care Diagnostics, LLC.
09 Feb 2026 Normal Justification: The overlooked software risks within risk documents indicate insufficient software lifecycle management.
Excerpt: FMEA documents do not identify any risks associated with the software included with, and necessary for, correct intended operation of the products.
View Details
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated
XL PRECISION TECHNOLOGIES LTD
29 Aug 2025 Normal Justification: Inadequately documented software validation procedures impact quality system's reliability.
Excerpt: You have not defined and documented written procedures for validation of all software utilized under the quality system.
View Details
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated
XL PRECISION TECHNOLOGIES LTD
29 Aug 2025 Normal Justification: Inadequately documented software validation procedures impact quality system's reliability.
Excerpt: You have not defined and documented written procedures for validation of all software utilized under the quality system.
View Details
Your firm failed to exercise appropriate controls for the electronic data acquisition systems
Fujifilm Diosynth Biotechnologies Texas, LLC
11 Mar 2025 Normal Justification: Inefficiencies in lifecycle management lead to lack of control over systems, affecting validation and data integrity.
Excerpt: User privilege settings in allow your QC analysts to perform patch processing or manual processing for unsaved live data.
View Details
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Philips Medical Systems Nederland B.V.
17 Jan 2025 Normal Justification: Software Lifecycle Management is implicated due to complaints linked to software coding issues not being escalated.
Excerpt: Review of complaint data download shows 127 out of the 436 complaints with software defects were not escalated.
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.

Software Lifecycle Management

Overview

10
Form 483s Issued
1
483s converted to WL
10
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
09 Feb 2026
Collaborative Care Diagnostics, LLC.
Drugs
29 Aug 2025
XL PRECISION TECHNOLOGIES LTD
Drugs
11 Mar 2025
Fujifilm Diosynth Biotechnologies Texas, LLC
Drugs
17 Jan 2025
Philips Medical Systems Nederland B.V.
Drugs
06 Nov 2024
ARUP Laboratories, Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kathleen B. Swat
3
0
Nadia R Barreda
2
0
Joshua J Silvestri
2
0
Janet Pulver
2
0
Dennis R Hock
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
One or more processes for risk management in product realization have not been adequately documented.
Collaborative Care Diagnostics, LLC.
09 Feb 2026 Normal Justification: The overlooked software risks within risk documents indicate insufficient software lifecycle management.
Excerpt: FMEA documents do not identify any risks associated with the software included with, and necessary for, correct intended operation of the products.
View Details
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated
XL PRECISION TECHNOLOGIES LTD
29 Aug 2025 Normal Justification: Inadequately documented software validation procedures impact quality system's reliability.
Excerpt: You have not defined and documented written procedures for validation of all software utilized under the quality system.
View Details
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated
XL PRECISION TECHNOLOGIES LTD
29 Aug 2025 Normal Justification: Inadequately documented software validation procedures impact quality system's reliability.
Excerpt: You have not defined and documented written procedures for validation of all software utilized under the quality system.
View Details
Your firm failed to exercise appropriate controls for the electronic data acquisition systems
Fujifilm Diosynth Biotechnologies Texas, LLC
11 Mar 2025 Normal Justification: Inefficiencies in lifecycle management lead to lack of control over systems, affecting validation and data integrity.
Excerpt: User privilege settings in allow your QC analysts to perform patch processing or manual processing for unsaved live data.
View Details
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Philips Medical Systems Nederland B.V.
17 Jan 2025 Normal Justification: Software Lifecycle Management is implicated due to complaints linked to software coding issues not being escalated.
Excerpt: Review of complaint data download shows 127 out of the 436 complaints with software defects were not escalated.
View Details

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