Investigations

Analytics Overview

181

Form 483s Issued

483s converted to WL

245

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

17 Apr 2026

Novel Laboratories, Inc. d.b.a Lupin

Drugs

View Form 483

27 Mar 2026

Bentley Laboratories LLC

Drugs

View Form 483

27 Mar 2026

Charles River Laboratories, Inc.

Drugs

View Form 483

20 Mar 2026

Bora Pharmaceuticals Injectables Inc

Drugs

View Form 483

11 Mar 2026

VET4U, LLC

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
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
Investigations of an unexplained discrepancy and failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product. Novel Laboratories, Inc. d.b.a Lupin	17 Apr 2026	Normal	Justification: The investigation process failed to adequately address potential impacts beyond the initially identified discrepancy. Excerpt: Investigations of an unexplained discrepancy… did not extend to other batches of the same drug product. View Details
There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. Bentley Laboratories LLC	27 Mar 2026	Normal	Justification: Failure to investigate and properly address microbial contamination highlights weaknesses in the investigation processes. Excerpt: The investigation failed to include a documented review of microbial results ... the hoses, used to drop the product from the kettles ... may not have been cleaned and sanitized thoroughly. View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications Bentley Laboratories LLC	27 Mar 2026	Normal	Justification: Investigations are critical for identifying root causes of contamination and preventing recurrence. Excerpt: No documented investigations were conducted when B. cepacia was identified... View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Bentley Laboratories LLC	27 Mar 2026	Normal	Justification: The observation highlights insufficient investigation for contamination and yield issues linked to the role of quality control. Excerpt: Specifically, 1) No investigation was initiated when the contract testing laboratory did not perform species identification on two Colony Forming Units of Gram-negative rods. View Details

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Investigations

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Overview

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Recent Form 483s

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Investigations

Overview

181

Form 483s Issued

483s converted to WL

245

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

17 Apr 2026

Novel Laboratories, Inc. d.b.a Lupin

Drugs

View Form 483

27 Mar 2026

Bentley Laboratories LLC

Drugs

View Form 483

27 Mar 2026

Charles River Laboratories, Inc.

Drugs

View Form 483

20 Mar 2026

Bora Pharmaceuticals Injectables Inc

Drugs

View Form 483

11 Mar 2026

VET4U, LLC

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
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
Investigations of an unexplained discrepancy and failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product. Novel Laboratories, Inc. d.b.a Lupin	17 Apr 2026	Normal	Justification: The investigation process failed to adequately address potential impacts beyond the initially identified discrepancy. Excerpt: Investigations of an unexplained discrepancy… did not extend to other batches of the same drug product. View Details
There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. Bentley Laboratories LLC	27 Mar 2026	Normal	Justification: Failure to investigate and properly address microbial contamination highlights weaknesses in the investigation processes. Excerpt: The investigation failed to include a documented review of microbial results ... the hoses, used to drop the product from the kettles ... may not have been cleaned and sanitized thoroughly. View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications Bentley Laboratories LLC	27 Mar 2026	Normal	Justification: Investigations are critical for identifying root causes of contamination and preventing recurrence. Excerpt: No documented investigations were conducted when B. cepacia was identified... View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Bentley Laboratories LLC	27 Mar 2026	Normal	Justification: The observation highlights insufficient investigation for contamination and yield issues linked to the role of quality control. Excerpt: Specifically, 1) No investigation was initiated when the contract testing laboratory did not perform species identification on two Colony Forming Units of Gram-negative rods. View Details

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