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Sub System /
Document Management
Document Management
View Detailed Analysis

Analytics Overview

166
Form 483s Issued
26
483s converted to WL
259
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483
26 Sep 2025
Baxter Onocology GmbH
Drugs
View Form 483
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
18
0
José E Melendez
18
12
Christy Osgood
18
0
David Carlson
18
0
LaiMing Lee
18
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Incomplete documentation practices directly affect Sample Testing procedures, as noted in the observation.
Excerpt: The SOP entitled, ‘ACCEPTABLE QUALITY LIMIT (AQL) TESTING OF 100 PERCENT STERILE INSPECTED CONTAINERS’...does not describe in detail.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Absence of written procedures highlights failures in document management related to quality control responsibilities.
Excerpt: Your firm has no written procedures for the responsibilities of the Quality Unit.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Observation reveals critical gaps in document management, impacting procedure establishment and adherence.
Excerpt: Your firm has no written procedure for how to separate multiple batch preparations to prevent contamination.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited		 21 Nov 2025 Normal Justification: The observation highlights missing procedures and undefined protocols, indicating a document management issue.
Excerpt: There is no written procedure that describes what is Non-routine Protocol and what is Miscellaneous sample.
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

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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

166
Form 483s Issued
26
483s converted to WL
259
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483
26 Sep 2025
Baxter Onocology GmbH
Drugs
View Form 483
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
18
0
José E Melendez
18
12
Christy Osgood
18
0
David Carlson
18
0
LaiMing Lee
18
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Incomplete documentation practices directly affect Sample Testing procedures, as noted in the observation.
Excerpt: The SOP entitled, ‘ACCEPTABLE QUALITY LIMIT (AQL) TESTING OF 100 PERCENT STERILE INSPECTED CONTAINERS’...does not describe in detail.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Absence of written procedures highlights failures in document management related to quality control responsibilities.
Excerpt: Your firm has no written procedures for the responsibilities of the Quality Unit.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Observation reveals critical gaps in document management, impacting procedure establishment and adherence.
Excerpt: Your firm has no written procedure for how to separate multiple batch preparations to prevent contamination.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited		 21 Nov 2025 Normal Justification: The observation highlights missing procedures and undefined protocols, indicating a document management issue.
Excerpt: There is no written procedure that describes what is Non-routine Protocol and what is Miscellaneous sample.
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

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