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Sub System /
Facility Design
Facility Design
View Detailed Analysis

Analytics Overview

134
Form 483s Issued
22
483s converted to WL
172
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
08 Apr 2026
Pharmaneek Inc
Drugs
View Form 483
22 Jan 2026
Excel Vision
Drugs
View Form 483
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Margaret M Annes
8
4
Justin A Boyd
8
2
Camerson E Moore
8
0
Christopher R Czajka
7
0
Edmund F Mrak
7
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Sufficient facility and equipment controls are in place to prevent contamination of and by the application product
Not available		 29 Jun 2026 Normal Justification: Facility design directly influences contamination control as inadequate design increases contamination risk.
Excerpt: Observe the firm's operations as you inspect the facility and after reviewing blueprints, floor plans, or as-built diagrams.
View Details
Your facility is not maintained in a good state of repair, creating insanitary conditions whereby drug products may be contaminated with filth.
Pharmaneek Inc		 08 Apr 2026 Normal Justification: Facility Design underpins environment cleanliness; a missing tile signifies a design failure affecting contamination control.
Excerpt: The ceiling tile was missing and opened to the plenum space, exposing the room to environmental contaminants.
View Details
Aseptic processing areas are deficient
Excel Vision		 22 Jan 2026 Normal Justification: Facility design inadequacies allow contamination, compromising aseptic conditions, evident from material deterioration and mold recovery.
Excerpt: Aseptic processing areas are deficient... materials have a risk of accelerated deterioration... inability to ensure complete decontamination.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: The defect in facility design compromises first pass air from reaching the filling line.
Excerpt: The design of the aseptic area does not promote unidirectional air flow.
View Details
Buildings and facilities used to manufacture APIs are not maintained appropriately
Ipca Laboratories Limited		 05 Dec 2025 Normal Justification: Structural deficiencies in clean rooms directly relate to Facility Design affecting cleanability and contamination risk.
Excerpt: Buildings and facilities used to manufacture APIs are not maintained appropriately to facilitate cleaning and to minimize potential contamination.
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.

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Facility Design

Overview

134
Form 483s Issued
22
483s converted to WL
172
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
08 Apr 2026
Pharmaneek Inc
Drugs
View Form 483
22 Jan 2026
Excel Vision
Drugs
View Form 483
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Margaret M Annes
8
4
Justin A Boyd
8
2
Camerson E Moore
8
0
Christopher R Czajka
7
0
Edmund F Mrak
7
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
Sufficient facility and equipment controls are in place to prevent contamination of and by the application product
Not available		 29 Jun 2026 Normal Justification: Facility design directly influences contamination control as inadequate design increases contamination risk.
Excerpt: Observe the firm's operations as you inspect the facility and after reviewing blueprints, floor plans, or as-built diagrams.
View Details
Your facility is not maintained in a good state of repair, creating insanitary conditions whereby drug products may be contaminated with filth.
Pharmaneek Inc		 08 Apr 2026 Normal Justification: Facility Design underpins environment cleanliness; a missing tile signifies a design failure affecting contamination control.
Excerpt: The ceiling tile was missing and opened to the plenum space, exposing the room to environmental contaminants.
View Details
Aseptic processing areas are deficient
Excel Vision		 22 Jan 2026 Normal Justification: Facility design inadequacies allow contamination, compromising aseptic conditions, evident from material deterioration and mold recovery.
Excerpt: Aseptic processing areas are deficient... materials have a risk of accelerated deterioration... inability to ensure complete decontamination.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: The defect in facility design compromises first pass air from reaching the filling line.
Excerpt: The design of the aseptic area does not promote unidirectional air flow.
View Details
Buildings and facilities used to manufacture APIs are not maintained appropriately
Ipca Laboratories Limited		 05 Dec 2025 Normal Justification: Structural deficiencies in clean rooms directly relate to Facility Design affecting cleanability and contamination risk.
Excerpt: Buildings and facilities used to manufacture APIs are not maintained appropriately to facilitate cleaning and to minimize potential contamination.
View Details

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