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Sub System /
Media Fill
Media Fill
View Detailed Analysis

Analytics Overview

58
Form 483s Issued
18
483s converted to WL
67
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 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Taichun Qin
6
1
Justin A Boyd
5
3
Tekalign Wondimu
5
2
Jazmine N Brown
4
3
Arsen Karapetyan
4
0

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, written and followed.
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Media fill studies not accommodating maximum hold times compromise sterility assurance.
Excerpt: Media fill studies failed to routinely incorporate the maximum hold times for these supplies used in aseptic processing.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the process
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Lack of media fills since August 2024 suggests gaps in procedure validation for sterile manufacturing.
Excerpt: C. Your firm has not performed media fills for any drug products since you started manufacturing and releasing sterile drugs from August 2024 to July 2025.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Lupin Limited		 17 Jul 2025 Normal Justification: The media fills should simulate production to validate aseptic conditions, which was inadequately handled.
Excerpt: Media fill interventions lacked fidelity to real production processes, questioning their validity.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Media Fill process issues evident with inadequate incubation and seal integrity checks, critical for sterility assurance.
Excerpt: Your firm does not incubate all integral vials during media fills (aseptic process simulation).
View Details
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have suitable construction to facilitate cleaning, maintenance, and proper operations.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: The inability to enter the Grade B supporting room due to media fill validation suggests inadequate accommodation for operational observation.
Excerpt: We were unable to enter the Grade B supporting room during filling operations due to gowning qualification requirements and media fill validation data.
View Details

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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.

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Media Fill

Overview

58
Form 483s Issued
18
483s converted to WL
67
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 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Taichun Qin
6
1
Justin A Boyd
5
3
Tekalign Wondimu
5
2
Jazmine N Brown
4
3
Arsen Karapetyan
4
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Media fill studies not accommodating maximum hold times compromise sterility assurance.
Excerpt: Media fill studies failed to routinely incorporate the maximum hold times for these supplies used in aseptic processing.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the process
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Lack of media fills since August 2024 suggests gaps in procedure validation for sterile manufacturing.
Excerpt: C. Your firm has not performed media fills for any drug products since you started manufacturing and releasing sterile drugs from August 2024 to July 2025.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Lupin Limited		 17 Jul 2025 Normal Justification: The media fills should simulate production to validate aseptic conditions, which was inadequately handled.
Excerpt: Media fill interventions lacked fidelity to real production processes, questioning their validity.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: Media Fill process issues evident with inadequate incubation and seal integrity checks, critical for sterility assurance.
Excerpt: Your firm does not incubate all integral vials during media fills (aseptic process simulation).
View Details
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have suitable construction to facilitate cleaning, maintenance, and proper operations.
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: The inability to enter the Grade B supporting room due to media fill validation suggests inadequate accommodation for operational observation.
Excerpt: We were unable to enter the Grade B supporting room during filling operations due to gowning qualification requirements and media fill validation data.
View Details

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