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Sub System /
CAPA
CAPA
View Detailed Analysis

Analytics Overview

74
Form 483s Issued
19
483s converted to WL
89
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
GenoGenix, LLC
Drugs
View Form 483
15 May 2025
Apothecary Pharma LLC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
View Warning Letter

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
9
3
Pratik S Upadhyay
7
3
Arsen Karapetyan
6
1
Jonah S Ufferfilge
4
0
Joseph A Piechocki
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: 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
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
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Apothecary Pharma LLC		 15 May 2025 Normal Justification: CAPA processes are crucial as the SOP for it is not finalized, impacting issue resolution mechanisms.
Excerpt: Failed to finalize SOP1011 Corrective Action/ Preventative Action (CAPA).
View Details
Procedures for corrective and preventive action have not been adequately established.
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: CAPA's role in identifying root causes and implementing solutions is crucial, as highlighted by repeated complaints.
Excerpt: Investigation report... failed to mention... previous investigations... potential root cause...
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: CAPAs performed but failed to prevent future occurrences indicating inadequate plan execution.
Excerpt: CAPA was completed and approved...did not support microbial growth.
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

74
Form 483s Issued
19
483s converted to WL
89
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
GenoGenix, LLC
Drugs
View Form 483
15 May 2025
Apothecary Pharma LLC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
View Warning Letter

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
9
3
Pratik S Upadhyay
7
3
Arsen Karapetyan
6
1
Jonah S Ufferfilge
4
0
Joseph A Piechocki
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: 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
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
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Apothecary Pharma LLC		 15 May 2025 Normal Justification: CAPA processes are crucial as the SOP for it is not finalized, impacting issue resolution mechanisms.
Excerpt: Failed to finalize SOP1011 Corrective Action/ Preventative Action (CAPA).
View Details
Procedures for corrective and preventive action have not been adequately established.
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: CAPA's role in identifying root causes and implementing solutions is crucial, as highlighted by repeated complaints.
Excerpt: Investigation report... failed to mention... previous investigations... potential root cause...
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: CAPAs performed but failed to prevent future occurrences indicating inadequate plan execution.
Excerpt: CAPA was completed and approved...did not support microbial growth.
View Details

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