Investigations

Analytics Overview

230

Form 483s Issued

483s converted to WL

295

Total Observation

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

03 Sep 2026

RC Outsourcing, LLC

Drugs

View Form 483

18 Aug 2026

Imprimis NJOF, LLC

Drugs

View Form 483

19 Jun 2026

Eugia Steriles Private Limited

Drugs

View Form 483

29 May 2026

Shilpa Medicare Limited

Drugs

View Form 483

15 May 2026

Mylan Laboratories Limited

Drugs

View Form 483

Top Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Justin A Boyd

José E Melendez

Arsen Karapetyan

Pratik S Upadhyay

Anastasia M Shields

Observations

View all Observations

TITLE/ COMPANY	Issue Date	Status	Details
There is a failure to thoroughly review any unexplained discrepancy RC Outsourcing, LLC	03 Sep 2026	Normal	Justification: The inability to identify root causes directly impacts the integrity of investigation processes. Excerpt: Sterility test failure investigations for aseptically re-packaged Avastin 1.25 mg/0.05 mL were inadequate. 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 Imprimis NJOF, LLC	18 Aug 2026	Normal	Justification: The failure to investigate and identify root causes of fiber-like material in drug products points to weak investigation processes. The investigations remained incomplete without supplier inputs, impacting product integrity. Excerpt: failed to conduct an adequate investigation to determine the root cause of cellulose, non-cellulose, and other fiber-like material. View Details
OBJECTIVE 1a: Manufacturing and laboratory capabilities, changes, deviations, and trends relating to the development of drug substances and drug products have been adequately evaluated to ensure readiness for manufacturing. Not available	29 Jun 2026	Normal	Justification: The observation focuses on the need for thorough evaluations of investigations, a key element in the Investigations process type. Excerpt: Assess whether events and investigations relevant to the proposed commercial manufacturing process have been appropriately evaluated. View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. Eugia Steriles Private Limited	19 Jun 2026	Normal	Justification: The lack of documentation in investigation records directly links to the Investigations process impacting resolution of manufacturing issues. Excerpt: Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. Eugia Steriles Private Limited	19 Jun 2026	Normal	Justification: The lack of documentation in investigation records directly links to the Investigations process impacting resolution of manufacturing issues. Excerpt: Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. View Details

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Investigations

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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Overview

Trends

Recent Form 483s

Top FDA Investigators

Key Observations

FAQ

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Investigations

Overview

230

Form 483s Issued

483s converted to WL

295

Total Observation

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

03 Sep 2026

RC Outsourcing, LLC

Drugs

View Form 483

18 Aug 2026

Imprimis NJOF, LLC

Drugs

View Form 483

19 Jun 2026

Eugia Steriles Private Limited

Drugs

View Form 483

29 May 2026

Shilpa Medicare Limited

Drugs

View Form 483

15 May 2026

Mylan Laboratories Limited

Drugs

View Form 483

Top FDA Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Justin A Boyd

José E Melendez

Arsen Karapetyan

Pratik S Upadhyay

Anastasia M Shields

Key Observations

TITLE/ COMPANY	Issue Date	Status	Details
There is a failure to thoroughly review any unexplained discrepancy RC Outsourcing, LLC	03 Sep 2026	Normal	Justification: The inability to identify root causes directly impacts the integrity of investigation processes. Excerpt: Sterility test failure investigations for aseptically re-packaged Avastin 1.25 mg/0.05 mL were inadequate. 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 Imprimis NJOF, LLC	18 Aug 2026	Normal	Justification: The failure to investigate and identify root causes of fiber-like material in drug products points to weak investigation processes. The investigations remained incomplete without supplier inputs, impacting product integrity. Excerpt: failed to conduct an adequate investigation to determine the root cause of cellulose, non-cellulose, and other fiber-like material. View Details
OBJECTIVE 1a: Manufacturing and laboratory capabilities, changes, deviations, and trends relating to the development of drug substances and drug products have been adequately evaluated to ensure readiness for manufacturing. Not available	29 Jun 2026	Normal	Justification: The observation focuses on the need for thorough evaluations of investigations, a key element in the Investigations process type. Excerpt: Assess whether events and investigations relevant to the proposed commercial manufacturing process have been appropriately evaluated. View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. Eugia Steriles Private Limited	19 Jun 2026	Normal	Justification: The lack of documentation in investigation records directly links to the Investigations process impacting resolution of manufacturing issues. Excerpt: Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. Eugia Steriles Private Limited	19 Jun 2026	Normal	Justification: The lack of documentation in investigation records directly links to the Investigations process impacting resolution of manufacturing issues. Excerpt: Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. View Details

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Analytics Overview

Analytics Overview

Recent Form 483s & Warning Letters

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Investigations

Investigations

Overview

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Recent Form 483s & Warning Letters

Top FDA Investigators

Key Observations

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