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Sub System /
CAPA
CAPA
View Detailed Analysis

Analytics Overview

72
Form 483s Issued
16
483s converted to WL
87
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 Formulations Technical Operations, FTO-11
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
20 Dec 2024
SCA Pharmaceuticals, LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
9
3
Pratik S Upadhyay
7
2
Arsen Karapetyan
6
1
Jonah S Ufferfilge
4
0
Joseph A Piechocki
4
0

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 Formulations Technical Operations, 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
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
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: Effective CAPA efforts require controlled adjustments with appropriate review to maintain product quality.
Excerpt: Operators have the ability to change the values for reject limits for each batch and to make changes during the batch.
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

72
Form 483s Issued
16
483s converted to WL
87
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 Formulations Technical Operations, FTO-11
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
20 Dec 2024
SCA Pharmaceuticals, LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
9
3
Pratik S Upadhyay
7
2
Arsen Karapetyan
6
1
Jonah S Ufferfilge
4
0
Joseph A Piechocki
4
0

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 Formulations Technical Operations, 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
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
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: Effective CAPA efforts require controlled adjustments with appropriate review to maintain product quality.
Excerpt: Operators have the ability to change the values for reject limits for each batch and to make changes during the batch.
View Details

Frequently Asked Questions

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