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Sub System /
Document Management
Document Management
View Detailed Analysis

Analytics Overview

130
Form 483s Issued
26
483s converted to WL
198
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
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
15 May 2025
Apothecary Pharma LLC
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
21
9
Pratik S Upadhyay
16
7
Arsen Karapetyan
12
0
Margaret M Annes
8
2
Anastasia M Shields
7
5

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Documents such as product reports not managed or tracked properly, leading to non-compliance.
Excerpt: You did not submit the required initial product report or the required biannual product report for June 2025.
View Details
Your firm failed to establish adequate written procedures for production and process controls
BSO, LLC		 27 Jun 2025 Normal Justification: Inadequate documentation hinders effective process controls and tracking of defects and inspector performance.
Excerpt: Your firm has an open investigation into the root cause of the 'Black Speck' defect without determining its source.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Document management failures noted with missing investigation reports and lacking documentation of review results.
Excerpt: Your firm's quality system does not adequately ensure that all investigations are properly documented and retained.
View Details
Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months
Apothecary Pharma LLC		 15 May 2025 Normal Justification: Document Management is implicated as the failure arises from improper handling and submission of required regulatory documents.
Excerpt: Your outsourcing facility failed to submit an initial product report to the FDA upon registration as a 503B outsourcing facility.
View Details
Written procedures for sanitation are not followed.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: Proper documentation is part of document management essential for verifying compliance and process execution.
Excerpt: "Your firm's cleaning log for Building 2, Room 1408... does not include (b) (4) cleaning documentation."
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

130
Form 483s Issued
26
483s converted to WL
198
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
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
15 May 2025
Apothecary Pharma LLC
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
21
9
Pratik S Upadhyay
16
7
Arsen Karapetyan
12
0
Margaret M Annes
8
2
Anastasia M Shields
7
5

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Documents such as product reports not managed or tracked properly, leading to non-compliance.
Excerpt: You did not submit the required initial product report or the required biannual product report for June 2025.
View Details
Your firm failed to establish adequate written procedures for production and process controls
BSO, LLC		 27 Jun 2025 Normal Justification: Inadequate documentation hinders effective process controls and tracking of defects and inspector performance.
Excerpt: Your firm has an open investigation into the root cause of the 'Black Speck' defect without determining its source.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Document management failures noted with missing investigation reports and lacking documentation of review results.
Excerpt: Your firm's quality system does not adequately ensure that all investigations are properly documented and retained.
View Details
Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months
Apothecary Pharma LLC		 15 May 2025 Normal Justification: Document Management is implicated as the failure arises from improper handling and submission of required regulatory documents.
Excerpt: Your outsourcing facility failed to submit an initial product report to the FDA upon registration as a 503B outsourcing facility.
View Details
Written procedures for sanitation are not followed.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: Proper documentation is part of document management essential for verifying compliance and process execution.
Excerpt: "Your firm's cleaning log for Building 2, Room 1408... does not include (b) (4) cleaning documentation."
View Details

Frequently Asked Questions

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