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Sub System /
CAPA
CAPA
View Detailed Analysis

Analytics Overview

81
Form 483s Issued
19
483s converted to WL
96
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
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
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
30 May 2025
Capricor, Inc.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
6
3
Pratik S Upadhyay
5
2
Joseph A Piechocki
5
2
Arsen Karapetyan
5
1
Jonah S Ufferfilge
4
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The Quality Unit has not established adequate procedural controls and oversight
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: CAPA is impaired because effectiveness evaluation depends on the integrity of environmental monitoring data.
Excerpt: Due to inaccurate and incomplete environmental monitoring data, the effectiveness of CAPA cannot be adequately assessed.
View Details
Written records of investigations into unexplained discrepancies do not always include the conclusion and follow-up.
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: Inadequate CAPA planning reflects poor root cause consideration and inadequate corrective measures implementation.
Excerpt: Corrective and Preventive Actions (CAPAs) are not always comprehensive to address root causes or adequately documented.
View Details
Failure to thoroughly review unexplained discrepancies and batch failures
GenoGenix, LLC		 18 Jul 2025 Normal Justification: CAPA processes were not initiated for unexplained discrepancies and OOS results as required.
Excerpt: Failed to initiate corrective and preventive actions (CAPA) or investigations for most of these OOS results.
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: The observations highlight persistent CAPA issues not adequately preventing recurring problems.
Excerpt: CAPA was focused only on the probable root cause for failure, but preventive actions were not adequate.
View Details
Written procedures are not followed
Capricor, Inc.		 30 May 2025 Normal Justification: CARs not being addressed within the required timeline points to a failure in CAPA management.
Excerpt: Corrective action reports (CARs) must be (b) (4) unless an extension is issued; CARs were past due with no record of a requested extension.
View Details

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Go back

CAPA

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

CAPA

Overview

81
Form 483s Issued
19
483s converted to WL
96
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
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
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
30 May 2025
Capricor, Inc.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
6
3
Pratik S Upadhyay
5
2
Joseph A Piechocki
5
2
Arsen Karapetyan
5
1
Jonah S Ufferfilge
4
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The Quality Unit has not established adequate procedural controls and oversight
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: CAPA is impaired because effectiveness evaluation depends on the integrity of environmental monitoring data.
Excerpt: Due to inaccurate and incomplete environmental monitoring data, the effectiveness of CAPA cannot be adequately assessed.
View Details
Written records of investigations into unexplained discrepancies do not always include the conclusion and follow-up.
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: Inadequate CAPA planning reflects poor root cause consideration and inadequate corrective measures implementation.
Excerpt: Corrective and Preventive Actions (CAPAs) are not always comprehensive to address root causes or adequately documented.
View Details
Failure to thoroughly review unexplained discrepancies and batch failures
GenoGenix, LLC		 18 Jul 2025 Normal Justification: CAPA processes were not initiated for unexplained discrepancies and OOS results as required.
Excerpt: Failed to initiate corrective and preventive actions (CAPA) or investigations for most of these OOS results.
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: The observations highlight persistent CAPA issues not adequately preventing recurring problems.
Excerpt: CAPA was focused only on the probable root cause for failure, but preventive actions were not adequate.
View Details
Written procedures are not followed
Capricor, Inc.		 30 May 2025 Normal Justification: CARs not being addressed within the required timeline points to a failure in CAPA management.
Excerpt: Corrective action reports (CARs) must be (b) (4) unless an extension is issued; CARs were past due with no record of a requested extension.
View Details

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