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Sub System /
Change Control
Change Control
View Detailed Analysis

Analytics Overview

55
Form 483s Issued
9
483s converted to WL
61
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
20 May 2026
Strides Pharma Science Ltd.
Drugs
View Form 483
27 Mar 2026
Bentley Laboratories LLC
Drugs
View Form 483
13 Mar 2026
Isorx Cyclotron Center
Drugs
View Form 483
10 Mar 2026
Hospira, Inc.
Drugs
View Form 483
20 Feb 2026
BioLife Plasma Services L.P.
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
Burnell M Henry
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
Each component is not tested for conformity with all written specifications for purity, strength, and quality.
Strides Pharma Science Ltd.		 20 May 2026 Normal Justification: Change Control is implicated due to delays in updating specifications after SOP changes were made.
Excerpt: The controlling specification document did not require the (b)(4) test, creating a gap between procedural requirements and the formal specification.
View Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Bentley Laboratories LLC		 27 Mar 2026 Normal Justification: Observation highlights changes to manufacturing processes occurred without proper change control, as detailed in SOP QA-002c.
Excerpt: The change in manufacturing process was implemented on 04/26/2024 without a Change Control per SOP QA-002c.
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

55
Form 483s Issued
9
483s converted to WL
61
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
20 May 2026
Strides Pharma Science Ltd.
Drugs
View Form 483
27 Mar 2026
Bentley Laboratories LLC
Drugs
View Form 483
13 Mar 2026
Isorx Cyclotron Center
Drugs
View Form 483
10 Mar 2026
Hospira, Inc.
Drugs
View Form 483
20 Feb 2026
BioLife Plasma Services L.P.
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
Burnell M Henry
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
Each component is not tested for conformity with all written specifications for purity, strength, and quality.
Strides Pharma Science Ltd.		 20 May 2026 Normal Justification: Change Control is implicated due to delays in updating specifications after SOP changes were made.
Excerpt: The controlling specification document did not require the (b)(4) test, creating a gap between procedural requirements and the formal specification.
View Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Bentley Laboratories LLC		 27 Mar 2026 Normal Justification: Observation highlights changes to manufacturing processes occurred without proper change control, as detailed in SOP QA-002c.
Excerpt: The change in manufacturing process was implemented on 04/26/2024 without a Change Control per SOP QA-002c.
View Details

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