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Sub System /
Deviations
Deviations
View Detailed Analysis

Analytics Overview

98
Form 483s Issued
12
483s converted to WL
117
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483
21 Nov 2025
Shilpa Medicare Limited
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
03 Sep 2025
Biocon Biologics Limited
Drugs
View Form 483

Top Investigators

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

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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 whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Observation mentions multiple unaddressed deviations that impact batch safety, highlighting flaws in the deviation management process.
Excerpt: IPQA signed the work order and determined that a deviation and subsequent investigation should be initiated. However, no deviation was initiated.
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 whether or not the batch has been already distributed.
Shilpa Medicare Limited		 21 Nov 2025 Normal Justification: The observation highlights deviations not initiated for critical alarms and cleaning activities.
Excerpt: Deviations are not initiated for critical alarms... The following number of impact assessment forms were issued...
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited		 21 Nov 2025 Normal Justification: The main issue is related to non-compliance in investigating batch deviations from impurity limits.
Excerpt: There were no investigations conducted for the (b)(4) batches that failed to meet the AI limit.
View 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 make a record of the conclusions and follow-up.
Biocon Biologics Limited		 03 Sep 2025 Normal Justification: Failure to review and address prior deviations indicates a gap in the deviation management process, leading to recurring issues.
Excerpt: OOS Investigation Report No. 199753 did not include a detailed assessment of previous similar OOSs or events.
View Details

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Deviations

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

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Deviations

Overview

98
Form 483s Issued
12
483s converted to WL
117
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483
21 Nov 2025
Shilpa Medicare Limited
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
03 Sep 2025
Biocon Biologics Limited
Drugs
View Form 483

Top FDA Investigators

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

Key Observations

TITLE/ COMPANY Issue Date Status 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 whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Observation mentions multiple unaddressed deviations that impact batch safety, highlighting flaws in the deviation management process.
Excerpt: IPQA signed the work order and determined that a deviation and subsequent investigation should be initiated. However, no deviation was initiated.
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 whether or not the batch has been already distributed.
Shilpa Medicare Limited		 21 Nov 2025 Normal Justification: The observation highlights deviations not initiated for critical alarms and cleaning activities.
Excerpt: Deviations are not initiated for critical alarms... The following number of impact assessment forms were issued...
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited		 21 Nov 2025 Normal Justification: The main issue is related to non-compliance in investigating batch deviations from impurity limits.
Excerpt: There were no investigations conducted for the (b)(4) batches that failed to meet the AI limit.
View 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 make a record of the conclusions and follow-up.
Biocon Biologics Limited		 03 Sep 2025 Normal Justification: Failure to review and address prior deviations indicates a gap in the deviation management process, leading to recurring issues.
Excerpt: OOS Investigation Report No. 199753 did not include a detailed assessment of previous similar OOSs or events.
View Details

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