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Sub System /
Document Management
Document Management
View Detailed Analysis

Analytics Overview

175
Form 483s Issued
26
483s converted to WL
247
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
26 Sep 2025
Hetero Labs Limited (Warehouse)
Drugs
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
John Doe
24
0
Jane Smith
24
0
José E Melendez
18
12
Justin A Boyd
15
5
Pratik S Upadhyay
11
3

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
There is no quality unit oversight.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: The lack of records and SOPs indicates direct correlation with deficiencies in document management processes.
Excerpt: There are no incoming and outgoing transportation records, incoming and outgoing shipment logs, and quality documentation for warehouse operations.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: The observation pertains to the lack of documentation and quality agreements, which are core aspects of Document Management.
Excerpt: There is no documentation at your facility that these samples were collected or documentation they were sent for analysis by the unregistered testing facility.
View Details
Your Quality Unit failed to adequately control documents.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: The observation specifically notes failures related to the control, verification, and destruction of GMP documents, a core aspect of document management.
Excerpt: GMP documents that were destroyed by tearing into pieces...signature does not match to that of his signature.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: The observation highlights a gap in documented procedures crucial for enforcing cGMP standards.
Excerpt: The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
View Details
Procedures for the preparation of master production and control records are not described in a written procedure
Fareva Amboise		 16 Sep 2025 Normal Justification: The observation highlights the need for clear document management protocols to ensure all documents are accounted for, preventing unauthorized destruction.
Excerpt: There is no process to reconcile the GMP forms printed from Master Control to determine whether all issued original GMP forms are used or returned to QA.
View Details

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Document Management

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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Document Management

Overview

175
Form 483s Issued
26
483s converted to WL
247
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
26 Sep 2025
Hetero Labs Limited (Warehouse)
Drugs
View Form 483
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
John Doe
24
0
Jane Smith
24
0
José E Melendez
18
12
Justin A Boyd
15
5
Pratik S Upadhyay
11
3

Key Observations

TITLE/ COMPANY Issue Date Status Details
There is no quality unit oversight.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: The lack of records and SOPs indicates direct correlation with deficiencies in document management processes.
Excerpt: There are no incoming and outgoing transportation records, incoming and outgoing shipment logs, and quality documentation for warehouse operations.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: The observation pertains to the lack of documentation and quality agreements, which are core aspects of Document Management.
Excerpt: There is no documentation at your facility that these samples were collected or documentation they were sent for analysis by the unregistered testing facility.
View Details
Your Quality Unit failed to adequately control documents.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: The observation specifically notes failures related to the control, verification, and destruction of GMP documents, a core aspect of document management.
Excerpt: GMP documents that were destroyed by tearing into pieces...signature does not match to that of his signature.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: The observation highlights a gap in documented procedures crucial for enforcing cGMP standards.
Excerpt: The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
View Details
Procedures for the preparation of master production and control records are not described in a written procedure
Fareva Amboise		 16 Sep 2025 Normal Justification: The observation highlights the need for clear document management protocols to ensure all documents are accounted for, preventing unauthorized destruction.
Excerpt: There is no process to reconcile the GMP forms printed from Master Control to determine whether all issued original GMP forms are used or returned to QA.
View Details

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