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Sub System /
Document Management
Document Management
View Detailed Analysis

Analytics Overview

177
Form 483s Issued
26
483s converted to WL
255
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
11 Mar 2026
VET4U, LLC
Drugs
View Form 483
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
View Form 483

Top Investigators

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

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Your firm does not have adequate systems and processes to enable compliance with the verification requirements of section 582(c) of Federal Food, Drug, and Cosmetic Act
VET4U, LLC		 11 Mar 2026 Normal Justification: Document Management is linked due to inadequate documentation for identifying and handling suspect products as per DSCSA.
Excerpt: Your Quality Document 390, titled Suspect Product, last reviewed on 06/02/2025, does not establish adequate systems and processes...
View Details
Production records do not contain complete information relating to the production and control of each batch
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation details the absence of a structured document control system, indicating improper management of original CGMP records.
Excerpt: These documents were not marked as copies, voided through an established procedure, or otherwise reconciled as part of an approved document control system.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Document Management is linked because the issue arises from improper handling and control of document destruction logs.
Excerpt: However, during review of the Shredding Machine Usage Logbook, it was observed that the individual who performed the document destruction also signed as the verifier.
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 whether or not the batch has been already distributed.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Inconsistencies in document issuance procedures indicate issues within the Document Management process.
Excerpt: Two copies of the Line Clearance Checklist were issued when only one was required.
View 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

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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

177
Form 483s Issued
26
483s converted to WL
255
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
11 Mar 2026
VET4U, LLC
Drugs
View Form 483
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
View Form 483

Top FDA Investigators

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

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm does not have adequate systems and processes to enable compliance with the verification requirements of section 582(c) of Federal Food, Drug, and Cosmetic Act
VET4U, LLC		 11 Mar 2026 Normal Justification: Document Management is linked due to inadequate documentation for identifying and handling suspect products as per DSCSA.
Excerpt: Your Quality Document 390, titled Suspect Product, last reviewed on 06/02/2025, does not establish adequate systems and processes...
View Details
Production records do not contain complete information relating to the production and control of each batch
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation details the absence of a structured document control system, indicating improper management of original CGMP records.
Excerpt: These documents were not marked as copies, voided through an established procedure, or otherwise reconciled as part of an approved document control system.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Document Management is linked because the issue arises from improper handling and control of document destruction logs.
Excerpt: However, during review of the Shredding Machine Usage Logbook, it was observed that the individual who performed the document destruction also signed as the verifier.
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 whether or not the batch has been already distributed.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Inconsistencies in document issuance procedures indicate issues within the Document Management process.
Excerpt: Two copies of the Line Clearance Checklist were issued when only one was required.
View 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

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