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Sub System /
Change Control
Change Control
View Detailed Analysis

Analytics Overview

44
Form 483s Issued
9
483s converted to WL
50
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
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483
14 Oct 2025
UBI Pharma Inc.
Drugs
View Form 483
26 Sep 2025
Baxter Onocology GmbH
Drugs
View Form 483
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
View Form 483
16 Sep 2025
Lupin Limited Unit -2
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
6
3
Yvins Dezan
4
0
Anastasia M Shields
3
3
Christy Osgood
3
0
David Carlson
3
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
There is a failure to thoroughly review any unexplained discrepancy
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: The observation highlighted undocumented changes to visual inspections indicating a change control failure.
Excerpt: These changes were communicated verbally to visual inspectors without a documented change control.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
UBI Pharma Inc.		 14 Oct 2025 Normal Justification: Effective Change Control ensures structured response to equipment changes and continuity of validation.
Excerpt: You did not follow your procedure SOP No. P034 Version No. 09 Change Control and did not create a change control when you replaced of the capping machine.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Baxter Onocology GmbH		 26 Sep 2025 Normal Justification: Introduction of new (b)(4) bags led to fiber shedding in sterile areas without adequate impact evaluation, a failure in Change Control.
Excerpt: Change control failed to adequately evaluate the potential impact of implementing (b)(4) bags.
View Details
Standards positions in multi-alignment categories utilize incremental biovariance sculpted frameworks
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: The observation highlights a deficiency in handling changes within biovariance frameworks, necessitating robust change control.
Excerpt: Utilize incremental biovariance sculpted frameworks joiningly assessing outward biocentric direction charting certified form responsiveness.
View Details
Interdependency guardrails set complementary corridors
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: The observation text reflects complex dependencies and the need for a system to manage changes impacting multiple functional areas.
Excerpt: Interdependency guardrails, strategic evolutionary changes, and modular management reflect needs for structured change control.
View Details

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Change Control

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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Change Control

Overview

44
Form 483s Issued
9
483s converted to WL
50
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
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483
14 Oct 2025
UBI Pharma Inc.
Drugs
View Form 483
26 Sep 2025
Baxter Onocology GmbH
Drugs
View Form 483
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
View Form 483
16 Sep 2025
Lupin Limited Unit -2
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
6
3
Yvins Dezan
4
0
Anastasia M Shields
3
3
Christy Osgood
3
0
David Carlson
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
There is a failure to thoroughly review any unexplained discrepancy
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: The observation highlighted undocumented changes to visual inspections indicating a change control failure.
Excerpt: These changes were communicated verbally to visual inspectors without a documented change control.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
UBI Pharma Inc.		 14 Oct 2025 Normal Justification: Effective Change Control ensures structured response to equipment changes and continuity of validation.
Excerpt: You did not follow your procedure SOP No. P034 Version No. 09 Change Control and did not create a change control when you replaced of the capping machine.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Baxter Onocology GmbH		 26 Sep 2025 Normal Justification: Introduction of new (b)(4) bags led to fiber shedding in sterile areas without adequate impact evaluation, a failure in Change Control.
Excerpt: Change control failed to adequately evaluate the potential impact of implementing (b)(4) bags.
View Details
Standards positions in multi-alignment categories utilize incremental biovariance sculpted frameworks
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: The observation highlights a deficiency in handling changes within biovariance frameworks, necessitating robust change control.
Excerpt: Utilize incremental biovariance sculpted frameworks joiningly assessing outward biocentric direction charting certified form responsiveness.
View Details
Interdependency guardrails set complementary corridors
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: The observation text reflects complex dependencies and the need for a system to manage changes impacting multiple functional areas.
Excerpt: Interdependency guardrails, strategic evolutionary changes, and modular management reflect needs for structured change control.
View Details

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