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Sub System /
Facility Design
Facility Design
View Detailed Analysis

Analytics Overview

144
Form 483s Issued
22
483s converted to WL
182
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
08 Apr 2026
Pharmaneek Inc
Drugs
View Form 483
10 Mar 2026
Hospira, Inc.
Drugs
View Form 483
06 Mar 2026
Aurorium LLC
Drugs
View Form 483
27 Feb 2026
Gasco Industrial Corp.
Drugs
View Form 483
24 Feb 2026
The SYGMA Network
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Margaret M Annes
8
4
Camerson E Moore
8
0
Justin A Boyd
8
2
Christopher R Czajka
7
0
Anastasia M Shields
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
Equipment and facilities in drug product manufacture are not adequately designed or located.
Hospira, Inc.		 10 Mar 2026 Normal Justification: Facility Design is linked to the inadequate design of the fill line lacking a HEPA filter.
Excerpt: Based on design, the fill line for drug product manufacture fails to have a HEPA filter directly above the stopper bowl.
View Details
Failure to properly maintain buildings, facilities and equipment used in the manufacture of active pharmaceutical ingredients
Aurorium LLC		 06 Mar 2026 Normal Justification: Facility design failures directly impact equipment durability and environmental conditions critical for API manufacturing.
Excerpt: Areas of the building that had excessive corrosion...deterioration of walls and floors...leaking from a pipe.
View Details
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
Gasco Industrial Corp.		 27 Feb 2026 Normal Justification: Proper facility design is critical to prevent contamination and maintain organization; failures led to observed risks.
Excerpt: Production room is exposed to exterior; insufficient space between pallets.
View Details

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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

144
Form 483s Issued
22
483s converted to WL
182
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
08 Apr 2026
Pharmaneek Inc
Drugs
View Form 483
10 Mar 2026
Hospira, Inc.
Drugs
View Form 483
06 Mar 2026
Aurorium LLC
Drugs
View Form 483
27 Feb 2026
Gasco Industrial Corp.
Drugs
View Form 483
24 Feb 2026
The SYGMA Network
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Margaret M Annes
8
4
Camerson E Moore
8
0
Justin A Boyd
8
2
Christopher R Czajka
7
0
Anastasia M Shields
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
Equipment and facilities in drug product manufacture are not adequately designed or located.
Hospira, Inc.		 10 Mar 2026 Normal Justification: Facility Design is linked to the inadequate design of the fill line lacking a HEPA filter.
Excerpt: Based on design, the fill line for drug product manufacture fails to have a HEPA filter directly above the stopper bowl.
View Details
Failure to properly maintain buildings, facilities and equipment used in the manufacture of active pharmaceutical ingredients
Aurorium LLC		 06 Mar 2026 Normal Justification: Facility design failures directly impact equipment durability and environmental conditions critical for API manufacturing.
Excerpt: Areas of the building that had excessive corrosion...deterioration of walls and floors...leaking from a pipe.
View Details
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
Gasco Industrial Corp.		 27 Feb 2026 Normal Justification: Proper facility design is critical to prevent contamination and maintain organization; failures led to observed risks.
Excerpt: Production room is exposed to exterior; insufficient space between pallets.
View Details

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