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Sub System /
Media Fill
Media Fill
View Detailed Analysis

Analytics Overview

81
Form 483s Issued
18
483s converted to WL
95
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
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
View Form 483
27 Feb 2026
EUGIA Pharma Specialities Limited
Drugs
View Form 483
27 Feb 2026
Reliance Life Sciences Private Limited
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
29 Jan 2026
Apotek Production & Laboratorier AB
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
10
1
Taichun Qin
6
1
Tekalign Wondimu
5
2
Jazmine N Brown
4
3
Anastasia M Shields
4
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
Bausch and Lomb Incorporated		 20 Mar 2026 Normal Justification: Inaccurate recording of media lots used directly impacts the reliability of sterility testing and data integrity.
Excerpt: Your firm failed to document all lots of media used in the preparation of In-House media.
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 Pharma Specialities Limited		 27 Feb 2026 Normal Justification: Media fill (aseptic process simulation) is directly linked as it validates the sterility of the aseptic processing line.
Excerpt: Specifically, there has been no aseptic process simulation (media fill) conducted since July 2022 for (b) (4) mg/mL.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Reliance Life Sciences Private Limited		 27 Feb 2026 Normal Justification: Media fill activities lack simulation of critical sealing activities and worst-case intervention conditions.
Excerpt: Your MF did not simulate the worst-case conditions relating to intervention frequency and duration.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Turbidity issues during media fill were traced to non-compliance in procedural handling by operators.
Excerpt: Operator used non-sanitized tools without performing glove sanitization during media fill.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Media fills should simulate normal operations as closely as possible to ensure containment measures are adequate.
Excerpt: Representative activities performed during smoke studies and media fill batch were not representative of routine commercial manufacturing.
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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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

81
Form 483s Issued
18
483s converted to WL
95
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
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
View Form 483
27 Feb 2026
EUGIA Pharma Specialities Limited
Drugs
View Form 483
27 Feb 2026
Reliance Life Sciences Private Limited
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
29 Jan 2026
Apotek Production & Laboratorier AB
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
10
1
Taichun Qin
6
1
Tekalign Wondimu
5
2
Jazmine N Brown
4
3
Anastasia M Shields
4
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
Bausch and Lomb Incorporated		 20 Mar 2026 Normal Justification: Inaccurate recording of media lots used directly impacts the reliability of sterility testing and data integrity.
Excerpt: Your firm failed to document all lots of media used in the preparation of In-House media.
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 Pharma Specialities Limited		 27 Feb 2026 Normal Justification: Media fill (aseptic process simulation) is directly linked as it validates the sterility of the aseptic processing line.
Excerpt: Specifically, there has been no aseptic process simulation (media fill) conducted since July 2022 for (b) (4) mg/mL.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Reliance Life Sciences Private Limited		 27 Feb 2026 Normal Justification: Media fill activities lack simulation of critical sealing activities and worst-case intervention conditions.
Excerpt: Your MF did not simulate the worst-case conditions relating to intervention frequency and duration.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Turbidity issues during media fill were traced to non-compliance in procedural handling by operators.
Excerpt: Operator used non-sanitized tools without performing glove sanitization during media fill.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Media fills should simulate normal operations as closely as possible to ensure containment measures are adequate.
Excerpt: Representative activities performed during smoke studies and media fill batch were not representative of routine commercial manufacturing.
View Details

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