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Sub System /
Change Control
Change Control
View Detailed Analysis

Analytics Overview

46
Form 483s Issued
9
483s converted to WL
52
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
29 Jun 2026
Not available
Drugs
View Form 483
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
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
OBJECTIVE 1a: Manufacturing and laboratory capabilities, changes, deviations, and trends relating to the development of drug substances and drug products have been adequately evaluated to ensure readiness for manufacturing.
Not available		 29 Jun 2026 Normal Justification: The observation highlights the need for proper documentation and assessment of changes, which falls under the Change Control process.
Excerpt: Investigative reports or resultant change control reports... may not always be as comprehensive as required.
View Details
Commitment to Quality in Pharmaceutical Development
Not available		 29 Jun 2026 Normal Justification: Change control procedures are crucial to managing scale-up and implementing new knowledge in the PQS.
Excerpt: Enable continual improvement through the change management system.
View Details
OBJECTIVE 1d: Adequate procedures exist for batch release, change management, and investigating failures, deviations, complaints, and adverse events.
Not available		 29 Jun 2026 Normal Justification: Change management impacts risk mitigation for product quality, especially when assessing need for ECs.
Excerpt: Verify that the firm's change management system assesses the need for new or revised ECs...
View 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

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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

46
Form 483s Issued
9
483s converted to WL
52
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
29 Jun 2026
Not available
Drugs
View Form 483
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
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
OBJECTIVE 1a: Manufacturing and laboratory capabilities, changes, deviations, and trends relating to the development of drug substances and drug products have been adequately evaluated to ensure readiness for manufacturing.
Not available		 29 Jun 2026 Normal Justification: The observation highlights the need for proper documentation and assessment of changes, which falls under the Change Control process.
Excerpt: Investigative reports or resultant change control reports... may not always be as comprehensive as required.
View Details
Commitment to Quality in Pharmaceutical Development
Not available		 29 Jun 2026 Normal Justification: Change control procedures are crucial to managing scale-up and implementing new knowledge in the PQS.
Excerpt: Enable continual improvement through the change management system.
View Details
OBJECTIVE 1d: Adequate procedures exist for batch release, change management, and investigating failures, deviations, complaints, and adverse events.
Not available		 29 Jun 2026 Normal Justification: Change management impacts risk mitigation for product quality, especially when assessing need for ECs.
Excerpt: Verify that the firm's change management system assesses the need for new or revised ECs...
View 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

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