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Sub System /
Facility Design
Facility Design
View Detailed Analysis

Analytics Overview

129
Form 483s Issued
22
483s converted to WL
167
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
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483
06 Nov 2025
Fresenius Kabi Compounding, LLC
Drugs
View Form 483
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
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
7
2
Christopher R Czajka
7
0
Edmund F Mrak
7
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
Fresenius Kabi Compounding, LLC		 06 Nov 2025 Normal Justification: The observation details physical condition issues directly tied to Facility Design, impacting clean room integrity critical in manufacturing.
Excerpt: Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
View Details
Evaluated fan computed nexus apex turnover space
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: Facility Design is directly affected due to poor management and escalation of space turnover processes.
Excerpt: Turnover space escalating embracing intentionally present sculpt governing project nav alternately effectively surged.
View Details
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: Facility design is directly related to the observation as the structural integrity issues compromise a clean and safe environment.
Excerpt: Leaky, corroded, and perforated ceilings and rainwater seeping through shipping doors and ceiling tiles.
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

129
Form 483s Issued
22
483s converted to WL
167
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
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483
06 Nov 2025
Fresenius Kabi Compounding, LLC
Drugs
View Form 483
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
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
7
2
Christopher R Czajka
7
0
Edmund F Mrak
7
2

Key Observations

TITLE/ COMPANY Issue Date Status 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
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
Fresenius Kabi Compounding, LLC		 06 Nov 2025 Normal Justification: The observation details physical condition issues directly tied to Facility Design, impacting clean room integrity critical in manufacturing.
Excerpt: Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
View Details
Evaluated fan computed nexus apex turnover space
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: Facility Design is directly affected due to poor management and escalation of space turnover processes.
Excerpt: Turnover space escalating embracing intentionally present sculpt governing project nav alternately effectively surged.
View Details
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: Facility design is directly related to the observation as the structural integrity issues compromise a clean and safe environment.
Excerpt: Leaky, corroded, and perforated ceilings and rainwater seeping through shipping doors and ceiling tiles.
View Details

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