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Sub System /
Deviations
Deviations
View Detailed Analysis

Analytics Overview

85
Form 483s Issued
12
483s converted to WL
102
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
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Arsen Karapetyan
6
0
Pratik S Upadhyay
5
1
Joseph A Piechocki
5
3
Carl Perez
4
0
Cynthia Jim, Consumer Safety Officer
4
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Manually managed materials in the warehouse and facilities are not separated during storage.
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: The inability to document incidents during walkthroughs indicates a laps in deviation management procedures.
Excerpt: No justification for your firm’s failure to open incidents as a result of deficiencies observed during Quality Walkthroughs.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Cohance Lifesciences Limited		 12 Aug 2025 Normal Justification: Deviation management is crucial in handling unexpected discrepancies in batch processing and storage.
Excerpt: There is no documentation on the disposition status and reconciliation of approximately (b)(4) of rejected tablets, (b)(4) mg, Batch No. (b)(4) that have gone missing.
View Details
Failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Deviations handling is directly impacted as no investigation followed the reported defects, showing a systemic inadequacy.
Excerpt: No investigation was performed to identify the root cause of these dark particulates.
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: Deviations not resolved effectively due to inadequate root cause identification and remediation.
Excerpt: Deviation number 200431248 was initiated... but the firm failed to demonstrate cleaning was repeatable.
View Details
Failure to thoroughly review unexplained discrepancies and batch failures
GenoGenix, LLC		 18 Jul 2025 Normal Justification: The observation specifically mentions a failure to address the deviation caused by the power outage, impacting sterility procedures.
Excerpt: Your firm failed to initiate an investigation after a power outage on July 12, 2025.
View Details

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Go back

Deviations

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

Deviations

Overview

85
Form 483s Issued
12
483s converted to WL
102
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
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Arsen Karapetyan
6
0
Pratik S Upadhyay
5
1
Joseph A Piechocki
5
3
Carl Perez
4
0
Cynthia Jim, Consumer Safety Officer
4
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Manually managed materials in the warehouse and facilities are not separated during storage.
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: The inability to document incidents during walkthroughs indicates a laps in deviation management procedures.
Excerpt: No justification for your firm’s failure to open incidents as a result of deficiencies observed during Quality Walkthroughs.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Cohance Lifesciences Limited		 12 Aug 2025 Normal Justification: Deviation management is crucial in handling unexpected discrepancies in batch processing and storage.
Excerpt: There is no documentation on the disposition status and reconciliation of approximately (b)(4) of rejected tablets, (b)(4) mg, Batch No. (b)(4) that have gone missing.
View Details
Failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Deviations handling is directly impacted as no investigation followed the reported defects, showing a systemic inadequacy.
Excerpt: No investigation was performed to identify the root cause of these dark particulates.
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: Deviations not resolved effectively due to inadequate root cause identification and remediation.
Excerpt: Deviation number 200431248 was initiated... but the firm failed to demonstrate cleaning was repeatable.
View Details
Failure to thoroughly review unexplained discrepancies and batch failures
GenoGenix, LLC		 18 Jul 2025 Normal Justification: The observation specifically mentions a failure to address the deviation caused by the power outage, impacting sterility procedures.
Excerpt: Your firm failed to initiate an investigation after a power outage on July 12, 2025.
View Details

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