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Sub System /
Investigations
Investigations
View Detailed Analysis

Analytics Overview

118
Form 483s Issued
23
483s converted to WL
174
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
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
16 May 2025
STAQ Pharma of Ohio, LLC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
04 Apr 2025
PQ Pharmacy LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
20
7
Arsen Karapetyan
16
4
Pratik S Upadhyay
14
5
Anastasia M Shields
8
5
Saleem A Akhtar
8
4

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Quality unit did not perform necessary investigations on chromatographic interruptions, risking incomplete sequence reviews.
Excerpt: No assessment was initiated until the current inspection despite integrity failures noted.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: Failing to conduct thorough investigations for media fill failures is a significant issue in the investigation process.
Excerpt: Media failure investigations from the Block vial line... were not thorough to identify root causes.
View Details
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications
STAQ Pharma of Ohio, LLC		 16 May 2025 Normal Justification: Thorough investigation processes are pivotal to identify and rectify root causes of defects.
Excerpt: After you confirmed the AQL failure you did not initiate an investigation to determine the 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: The observation highlights deficiencies in investigation processes for discrepancies and out-of-specification results.
Excerpt: Investigation Report for Device Malfunction for Solution USP, Complaint Number A-PC2024-001...your investigation failed to mention that previously, investigations...were initiated.
View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up
PQ Pharmacy LLC		 04 Apr 2025 Normal Justification: The investigation process failed to determine the root cause of contamination or evaluate potential concerns, inhibiting effective CAPA.
Excerpt: However, the investigation was inadequate as it did not establish a definitive root cause for the presence of visible particulates.
View Details

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Go back

Investigations

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

Investigations

Overview

118
Form 483s Issued
23
483s converted to WL
174
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
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
16 May 2025
STAQ Pharma of Ohio, LLC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
04 Apr 2025
PQ Pharmacy LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
20
7
Arsen Karapetyan
16
4
Pratik S Upadhyay
14
5
Anastasia M Shields
8
5
Saleem A Akhtar
8
4

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Quality unit did not perform necessary investigations on chromatographic interruptions, risking incomplete sequence reviews.
Excerpt: No assessment was initiated until the current inspection despite integrity failures noted.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: Failing to conduct thorough investigations for media fill failures is a significant issue in the investigation process.
Excerpt: Media failure investigations from the Block vial line... were not thorough to identify root causes.
View Details
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications
STAQ Pharma of Ohio, LLC		 16 May 2025 Normal Justification: Thorough investigation processes are pivotal to identify and rectify root causes of defects.
Excerpt: After you confirmed the AQL failure you did not initiate an investigation to determine the 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: The observation highlights deficiencies in investigation processes for discrepancies and out-of-specification results.
Excerpt: Investigation Report for Device Malfunction for Solution USP, Complaint Number A-PC2024-001...your investigation failed to mention that previously, investigations...were initiated.
View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up
PQ Pharmacy LLC		 04 Apr 2025 Normal Justification: The investigation process failed to determine the root cause of contamination or evaluate potential concerns, inhibiting effective CAPA.
Excerpt: However, the investigation was inadequate as it did not establish a definitive root cause for the presence of visible particulates.
View Details

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