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Sub System /
Data Backup and Recovery
Data Backup and Recovery
View Detailed Analysis

Analytics Overview

10
Form 483s Issued
2
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
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter
29 Feb 2024
Eugia SEZ Private Limited
Drugs
View Form 483
09 Nov 2023
Shilpa Medicare Limited
Drugs
View Form 483
08 Sep 2023
IDT Biologika GmbH
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Marcellinus Dordunoo
2
0
Brandon L Mariner
1
0
Brian Janelsins, PhD
1
0
Charles Yuan-Chia Kuo, PhD
1
0
Ashar P Parikh
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Failure to maintain a backup file of data entered into the computer or related system.
Sumitomo Pharma Co., Ltd.		 07 Aug 2025 Normal Justification: The observation highlights a failure in maintaining backups, directly implicating Data Backup and Recovery processes.
Excerpt: Specifically, your firm does not maintain complete backups of original electronic data generated by the (b) (4) visual inspection instrument.
View Details
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: The observation noted that prior data was not fully backed up before transitioning to a new system, leading to risks of data loss and integrity compromises.
Excerpt: The implementation of Phase was deficient due to failure to perform complete backup of the data that was previously generated.
View Details
Failure to maintain a backup file of data entered into the computer or related system
Eugia SEZ Private Limited		 29 Feb 2024 Normal Justification: The observation directly mentions a failure to maintain backup files for critical data, specifically noting that current practices lack function to save data internally or via backup.
Excerpt: Failure to maintain a backup file of data entered into the computer or related system.
View Details
You failed to maintain a backup file of data entered into the computer or related system.
Shilpa Medicare Limited		 09 Nov 2023 Normal Justification: The issue stems from a failure to properly execute and ensure robust data backup and recovery processes, leading to significant data loss.
Excerpt: "Your procedure, SMLJ/ITD/SOP-GEN/002-01 Back up, Restore, Verification and Archival of Electronic Data ... does not ensure that the complete data from your standalone laboratory equipment are backed up securely."
View Details
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping (b) (4) systems.
IDT Biologika GmbH		 08 Sep 2023 Normal Justification: Data Backup and Recovery processes are directly linked to ensuring data is exact, complete, and secure as mentioned in the observation.
Excerpt: The firm’s Quality Unit including Quality Control Molecular Biology lab manager and IT staff do not perform (b)(4) audits.
View Details

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Go back

Data Backup and Recovery

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

Data Backup and Recovery

Overview

10
Form 483s Issued
2
483s converted to WL
10
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
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter
29 Feb 2024
Eugia SEZ Private Limited
Drugs
View Form 483
09 Nov 2023
Shilpa Medicare Limited
Drugs
View Form 483
08 Sep 2023
IDT Biologika GmbH
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Marcellinus Dordunoo
2
0
Brandon L Mariner
1
0
Brian Janelsins, PhD
1
0
Charles Yuan-Chia Kuo, PhD
1
0
Ashar P Parikh
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Failure to maintain a backup file of data entered into the computer or related system.
Sumitomo Pharma Co., Ltd.		 07 Aug 2025 Normal Justification: The observation highlights a failure in maintaining backups, directly implicating Data Backup and Recovery processes.
Excerpt: Specifically, your firm does not maintain complete backups of original electronic data generated by the (b) (4) visual inspection instrument.
View Details
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: The observation noted that prior data was not fully backed up before transitioning to a new system, leading to risks of data loss and integrity compromises.
Excerpt: The implementation of Phase was deficient due to failure to perform complete backup of the data that was previously generated.
View Details
Failure to maintain a backup file of data entered into the computer or related system
Eugia SEZ Private Limited		 29 Feb 2024 Normal Justification: The observation directly mentions a failure to maintain backup files for critical data, specifically noting that current practices lack function to save data internally or via backup.
Excerpt: Failure to maintain a backup file of data entered into the computer or related system.
View Details
You failed to maintain a backup file of data entered into the computer or related system.
Shilpa Medicare Limited		 09 Nov 2023 Normal Justification: The issue stems from a failure to properly execute and ensure robust data backup and recovery processes, leading to significant data loss.
Excerpt: "Your procedure, SMLJ/ITD/SOP-GEN/002-01 Back up, Restore, Verification and Archival of Electronic Data ... does not ensure that the complete data from your standalone laboratory equipment are backed up securely."
View Details
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping (b) (4) systems.
IDT Biologika GmbH		 08 Sep 2023 Normal Justification: Data Backup and Recovery processes are directly linked to ensuring data is exact, complete, and secure as mentioned in the observation.
Excerpt: The firm’s Quality Unit including Quality Control Molecular Biology lab manager and IT staff do not perform (b)(4) audits.
View Details

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