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Sub System /
Deviations
Deviations
View Detailed Analysis

Analytics Overview

71
Form 483s Issued
6
483s converted to WL
88
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
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483
09 May 2025
LEESAR, INC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
8
1
Arsen Karapetyan
5
0
Joseph A Piechocki
4
0
Cynthia Jim, Consumer Safety Officer
4
0
Justin A Boyd
4
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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 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
Written production and process control procedures are not followed
Center for Drug Evaluation and Research		 11 Jul 2025 Normal Justification: The lack of reporting and investigating discrepancies indicates deviation management procedures were not followed.
Excerpt: discrepancies and failures were not reported or investigated as required by your written procedures.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
LEESAR, INC		 09 May 2025 Normal Justification: The observation highlights deviation handling issues, directly linking it to incorrect classification per established procedures.
Excerpt: Your quality unit is not following written procedure 6-8 rev 03 Quality Events and Investigations Management Process.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Repeated deviations noted without full root cause evaluation or effective remediation.
Excerpt: Your firm received over a hundred (100) complaints for malfunction...indicates...corrective and preventive actions were not adequate.
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

71
Form 483s Issued
6
483s converted to WL
88
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
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483
09 May 2025
LEESAR, INC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
8
1
Arsen Karapetyan
5
0
Joseph A Piechocki
4
0
Cynthia Jim, Consumer Safety Officer
4
0
Justin A Boyd
4
1

Key Observations

TITLE/ COMPANY Issue Date Status 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 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
Written production and process control procedures are not followed
Center for Drug Evaluation and Research		 11 Jul 2025 Normal Justification: The lack of reporting and investigating discrepancies indicates deviation management procedures were not followed.
Excerpt: discrepancies and failures were not reported or investigated as required by your written procedures.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
LEESAR, INC		 09 May 2025 Normal Justification: The observation highlights deviation handling issues, directly linking it to incorrect classification per established procedures.
Excerpt: Your quality unit is not following written procedure 6-8 rev 03 Quality Events and Investigations Management Process.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Repeated deviations noted without full root cause evaluation or effective remediation.
Excerpt: Your firm received over a hundred (100) complaints for malfunction...indicates...corrective and preventive actions were not adequate.
View Details

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