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Sub System /
CAPA
CAPA
View Detailed Analysis

Analytics Overview

94
Form 483s Issued
19
483s converted to WL
111
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
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483
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
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
8
3
Pratik S Upadhyay
5
2
Joseph A Piechocki
5
2
Arsen Karapetyan
5
1
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 to meet any of its specification
Empower Clinic Services, L.L.C. dba Empower Pharma		 14 Nov 2025 Normal Justification: No CAPA generated for poor practices and untimely investigations, despite impacting quality system.
Excerpt: No nonconformance, or CAPA had been generated to document, evaluate, or substantiate these behaviors within the quality system.
View 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
FARMAKEIO OUTSOURCING LLC		 05 Sep 2025 Normal Justification: The observation highlights failures in handling CAPA related to metal contamination, making CAPA a critical process type.
Excerpt: failed to adequately investigate and initiate corrective and preventive actions for CAPA #, CAPA-2025-0002 dated 03 Apr 2025.
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
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

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Uncover Trends: FDA Investigator profiles & Observations.
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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

94
Form 483s Issued
19
483s converted to WL
111
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
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483
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
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
8
3
Pratik S Upadhyay
5
2
Joseph A Piechocki
5
2
Arsen Karapetyan
5
1
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 to meet any of its specification
Empower Clinic Services, L.L.C. dba Empower Pharma		 14 Nov 2025 Normal Justification: No CAPA generated for poor practices and untimely investigations, despite impacting quality system.
Excerpt: No nonconformance, or CAPA had been generated to document, evaluate, or substantiate these behaviors within the quality system.
View 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
FARMAKEIO OUTSOURCING LLC		 05 Sep 2025 Normal Justification: The observation highlights failures in handling CAPA related to metal contamination, making CAPA a critical process type.
Excerpt: failed to adequately investigate and initiate corrective and preventive actions for CAPA #, CAPA-2025-0002 dated 03 Apr 2025.
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
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

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