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Sub System /
Media Fill
Media Fill
View Detailed Analysis

Analytics Overview

90
Form 483s Issued
18
483s converted to WL
105
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
18 Aug 2026
Imprimis NJOF, LLC
Drugs
View Form 483
19 Jun 2026
Eugia Steriles Private Limited
Drugs
View Form 483
24 Apr 2026
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
Drugs
View Form 483
27 Mar 2026
Q-Med AB
Drugs
View Form 483
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
10
1
Robert J. Ham
7
0
Taichun Qin
6
1
Karen A Briggs
5
0
Tekalign Wondimu
5
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 and sterilization process
Imprimis NJOF, LLC		 18 Aug 2026 Normal Justification: Media fill processes are crucial to validate as they simulate real-world aseptic production conditions.
Excerpt: Your firm’s aseptic process simulation (media fill) did not simulate the most challenging and stressful conditions.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: Media Fill process type is impacted due to the lack of intervention consistency and documentation in media fill batches.
Excerpt: One (1) out of the media fill batches fo mL media fill vials did not include the following intervention.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: Media Fill process type is impacted due to the lack of intervention consistency and documentation in media fill batches.
Excerpt: One (1) out of the media fill batches fo mL media fill vials did not include the following intervention.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.		 24 Apr 2026 Normal Justification: Media fills failing to incorporate actual conditions directly impact their validity as aseptic operation qualifiers.
Excerpt: Media fills are not representative of commercial manufacturing. Only the duration of an intervention is simulated.
View Details
Procedures designed to simulate aseptic processes are inadequate to assure the sterility of the drug product.
Q-Med AB		 27 Mar 2026 Normal Justification: Media Fill is linked as the observation highlights procedural gaps during the simulation of aseptic processes.
Excerpt: Vials exposed during media fill interventions are excluded/omitted from incubation.
View Details

Prepare Better for FDA Audits with FDA Tracker

Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
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Go back

Media Fill

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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Media Fill

Overview

90
Form 483s Issued
18
483s converted to WL
105
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
18 Aug 2026
Imprimis NJOF, LLC
Drugs
View Form 483
19 Jun 2026
Eugia Steriles Private Limited
Drugs
View Form 483
24 Apr 2026
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
Drugs
View Form 483
27 Mar 2026
Q-Med AB
Drugs
View Form 483
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
10
1
Robert J. Ham
7
0
Taichun Qin
6
1
Karen A Briggs
5
0
Tekalign Wondimu
5
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 and sterilization process
Imprimis NJOF, LLC		 18 Aug 2026 Normal Justification: Media fill processes are crucial to validate as they simulate real-world aseptic production conditions.
Excerpt: Your firm’s aseptic process simulation (media fill) did not simulate the most challenging and stressful conditions.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: Media Fill process type is impacted due to the lack of intervention consistency and documentation in media fill batches.
Excerpt: One (1) out of the media fill batches fo mL media fill vials did not include the following intervention.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: Media Fill process type is impacted due to the lack of intervention consistency and documentation in media fill batches.
Excerpt: One (1) out of the media fill batches fo mL media fill vials did not include the following intervention.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.		 24 Apr 2026 Normal Justification: Media fills failing to incorporate actual conditions directly impact their validity as aseptic operation qualifiers.
Excerpt: Media fills are not representative of commercial manufacturing. Only the duration of an intervention is simulated.
View Details
Procedures designed to simulate aseptic processes are inadequate to assure the sterility of the drug product.
Q-Med AB		 27 Mar 2026 Normal Justification: Media Fill is linked as the observation highlights procedural gaps during the simulation of aseptic processes.
Excerpt: Vials exposed during media fill interventions are excluded/omitted from incubation.
View Details

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