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Sub System /
Facility Design
Facility Design
View Detailed Analysis

Analytics Overview

116
Form 483s Issued
15
483s converted to WL
154
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
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
14 Feb 2025
Glenmark Pharmaceuticals Ltd
Drugs
View Form 483
24 Jan 2025
Carolina Infusion
Drugs
View Form 483
16 Jan 2025
Sanofi-Aventis Deutschland GmbH
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
10
3
Camerson E Moore
8
0
Margaret M Annes
8
4
Christopher R Czajka
7
0
Arsen Karapetyan
7
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have suitable construction to facilitate cleaning, maintenance, and proper operations.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Facility design flaws are evident by the inability to observe operations from designated viewing areas, impairing aseptic processing control.
Excerpt: Your Unit (b)(4) aseptic processing area is not adequately visible from the (b)(4) viewing windows.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations
Glenmark Pharmaceuticals Ltd		 14 Feb 2025 Normal Justification: Facility design is a key contributor as improper separation of high-risk drug products enables contamination due to shared usage of critical processing environments.
Excerpt: Separate, or defined areas to prevent contamination are deficient regarding manufacturing of drug products.
View Details
Smoke studies were inadequately performed under dynamic conditions
Carolina Infusion		 24 Jan 2025 Normal Justification: Facility design involves airflow systems that must be properly evaluated to maintain ISO 5 classification in dynamic conditions.
Excerpt: The most recent smoke study showed airflow compliance but lacked dynamic condition verification.
View Details
DS manufacturing area is not under control to assure product quality.
Sanofi-Aventis Deutschland GmbH		 16 Jan 2025 Normal Justification: Facility Design is integral to providing the structural and systematic foundation for maintaining controlled environmental conditions necessary for manufacturing.
Excerpt: Step are performed in an area of the Building that is classified as zone (b) (4).
View Details
Buildings used in the manufacturing of Intermediates and finished APIs are not maintained in a good state of repair.
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: The observation highlights poor maintenance which is a fundamental aspect of facility design affecting production areas.
Excerpt: Buildings used in the manufacturing of Intermediates and finished APIs are not maintained in a good state of repair.
View Details

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Go back

Facility Design

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

Facility Design

Overview

116
Form 483s Issued
15
483s converted to WL
154
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
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
14 Feb 2025
Glenmark Pharmaceuticals Ltd
Drugs
View Form 483
24 Jan 2025
Carolina Infusion
Drugs
View Form 483
16 Jan 2025
Sanofi-Aventis Deutschland GmbH
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
10
3
Camerson E Moore
8
0
Margaret M Annes
8
4
Christopher R Czajka
7
0
Arsen Karapetyan
7
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have suitable construction to facilitate cleaning, maintenance, and proper operations.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Facility design flaws are evident by the inability to observe operations from designated viewing areas, impairing aseptic processing control.
Excerpt: Your Unit (b)(4) aseptic processing area is not adequately visible from the (b)(4) viewing windows.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations
Glenmark Pharmaceuticals Ltd		 14 Feb 2025 Normal Justification: Facility design is a key contributor as improper separation of high-risk drug products enables contamination due to shared usage of critical processing environments.
Excerpt: Separate, or defined areas to prevent contamination are deficient regarding manufacturing of drug products.
View Details
Smoke studies were inadequately performed under dynamic conditions
Carolina Infusion		 24 Jan 2025 Normal Justification: Facility design involves airflow systems that must be properly evaluated to maintain ISO 5 classification in dynamic conditions.
Excerpt: The most recent smoke study showed airflow compliance but lacked dynamic condition verification.
View Details
DS manufacturing area is not under control to assure product quality.
Sanofi-Aventis Deutschland GmbH		 16 Jan 2025 Normal Justification: Facility Design is integral to providing the structural and systematic foundation for maintaining controlled environmental conditions necessary for manufacturing.
Excerpt: Step are performed in an area of the Building that is classified as zone (b) (4).
View Details
Buildings used in the manufacturing of Intermediates and finished APIs are not maintained in a good state of repair.
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: The observation highlights poor maintenance which is a fundamental aspect of facility design affecting production areas.
Excerpt: Buildings used in the manufacturing of Intermediates and finished APIs are not maintained in a good state of repair.
View Details

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