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Sub System /
Document Management
Document Management
View Detailed Analysis

Analytics Overview

138
Form 483s Issued
26
483s converted to WL
208
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
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
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
18
12
Justin A Boyd
14
5
Pratik S Upadhyay
11
3
Arsen Karapetyan
9
0
Margaret M Annes
8
2

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 firm failed to establish adequate document control
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: Document Management is the process type affected as it deals with controlling how documents are managed, approved, and released within the system.
Excerpt: The current DOCHUB system permits users to download approved documents in Microsoft Word format without embedded approval signatures.
View Details
Document control procedures under Quality Unit oversight are inadequate.
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: Issues arise from undocumented quality walkthroughs and improper document disposal, directly linked to Document Management failures.
Excerpt: Document control procedures under Quality Unit oversight are inadequate... an "informal quality walkthrough" that was not documented.
View Details

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Go back

Document Management

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

Document Management

Overview

138
Form 483s Issued
26
483s converted to WL
208
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
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
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
18
12
Justin A Boyd
14
5
Pratik S Upadhyay
11
3
Arsen Karapetyan
9
0
Margaret M Annes
8
2

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 firm failed to establish adequate document control
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: Document Management is the process type affected as it deals with controlling how documents are managed, approved, and released within the system.
Excerpt: The current DOCHUB system permits users to download approved documents in Microsoft Word format without embedded approval signatures.
View Details
Document control procedures under Quality Unit oversight are inadequate.
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: Issues arise from undocumented quality walkthroughs and improper document disposal, directly linked to Document Management failures.
Excerpt: Document control procedures under Quality Unit oversight are inadequate... an "informal quality walkthrough" that was not documented.
View Details

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