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Sub System /
CAPA
CAPA
View Detailed Analysis

Analytics Overview

110
Form 483s Issued
19
483s converted to WL
128
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
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
20 Mar 2026
Abbisko Therapeutics Co., Ltd.
Drugs
View Form 483
13 Mar 2026
Isorx Cyclotron Center
Drugs
View Form 483
12 Mar 2026
Custom Analytics LLC
Drugs
View Form 483
06 Mar 2026
Aurorium LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
8
3
Arsen Karapetyan
6
1
Joseph A Piechocki
5
2
Pratik S Upadhyay
5
2
Wayne D Mcgrath
5
1

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
Alkem Laboratories Limited		 01 May 2026 Normal Justification: Observation highlights repeated inadequacies due to ineffective root cause identification and CAPA implementation.
Excerpt: CAPA taken is inadequate to determine the risk to the drug products sold into the US market.
View Details
Failure to ensure the study is conducted in accordance with the protocol and/or investigational plan
Abbisko Therapeutics Co., Ltd.		 20 Mar 2026 Normal Justification: CAPA is critical as the delayed initiation suggests failures in response to quality breaches.
Excerpt: A corrective and preventive action (CAPA) plan was not initiated by your firm until January 2026.
View Details
You did not have written production and process control procedures to ensure that any deviations from the procedures are justified.
Isorx Cyclotron Center		 13 Mar 2026 Normal Justification: CAPA management is directly related to open corrective actions with lack of updates.
Excerpt: CAPA still open with outstanding work not completed and no additional comments of status.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Custom Analytics LLC		 12 Mar 2026 Normal Justification: CAPA process applies because it involves failure in corrective and preventive action implementation as per SOPs.
Excerpt: The investigation documentation did not include a documented root cause determination.
View Details
Failure of the Quality Unit to fulfill its oversight responsibilities
Aurorium LLC		 06 Mar 2026 Normal Justification: CAPA linkage is due to inadequate documentation and closure as per Corrective and Preventative Actions SOP.
Excerpt: CAPAs are not fully documented in accordance with your established procedure entitled Corrective and Preventative Actions.
View Details

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CAPA

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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CAPA

Overview

110
Form 483s Issued
19
483s converted to WL
128
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
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
20 Mar 2026
Abbisko Therapeutics Co., Ltd.
Drugs
View Form 483
13 Mar 2026
Isorx Cyclotron Center
Drugs
View Form 483
12 Mar 2026
Custom Analytics LLC
Drugs
View Form 483
06 Mar 2026
Aurorium LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
8
3
Arsen Karapetyan
6
1
Joseph A Piechocki
5
2
Pratik S Upadhyay
5
2
Wayne D Mcgrath
5
1

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
Alkem Laboratories Limited		 01 May 2026 Normal Justification: Observation highlights repeated inadequacies due to ineffective root cause identification and CAPA implementation.
Excerpt: CAPA taken is inadequate to determine the risk to the drug products sold into the US market.
View Details
Failure to ensure the study is conducted in accordance with the protocol and/or investigational plan
Abbisko Therapeutics Co., Ltd.		 20 Mar 2026 Normal Justification: CAPA is critical as the delayed initiation suggests failures in response to quality breaches.
Excerpt: A corrective and preventive action (CAPA) plan was not initiated by your firm until January 2026.
View Details
You did not have written production and process control procedures to ensure that any deviations from the procedures are justified.
Isorx Cyclotron Center		 13 Mar 2026 Normal Justification: CAPA management is directly related to open corrective actions with lack of updates.
Excerpt: CAPA still open with outstanding work not completed and no additional comments of status.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Custom Analytics LLC		 12 Mar 2026 Normal Justification: CAPA process applies because it involves failure in corrective and preventive action implementation as per SOPs.
Excerpt: The investigation documentation did not include a documented root cause determination.
View Details
Failure of the Quality Unit to fulfill its oversight responsibilities
Aurorium LLC		 06 Mar 2026 Normal Justification: CAPA linkage is due to inadequate documentation and closure as per Corrective and Preventative Actions SOP.
Excerpt: CAPAs are not fully documented in accordance with your established procedure entitled Corrective and Preventative Actions.
View Details

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