Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST. Save Your Seat
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Sub System /
Media Fill
Media Fill
View Detailed Analysis

Analytics Overview

55
Form 483s Issued
11
483s converted to WL
64
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
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483
03 Apr 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Tekalign Wondimu
5
0
Justin A Boyd
5
2
Taichun Qin
5
1
Jazmine N Brown
4
2
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 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
Batch production and control records do not include complete information relating to the production and control of each batch.
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: Media fill issues highlight core lapses in simulating real production conditions, directly impacting aseptic process validation.
Excerpt: Aseptic Process Simulation In-process fill checks involve passing a During media fills the is kept into the Grade A area, inside the barrier and the vials are holding the above the level...
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
Stokes Healthcare Inc. dba Epicur Pharma		 23 May 2025 Normal Justification: Media fill not reflective of actual conditions led to potential risks not being addressed during validation.
Excerpt: However, during routine production... media fill study...
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

55
Form 483s Issued
11
483s converted to WL
64
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
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483
03 Apr 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Tekalign Wondimu
5
0
Justin A Boyd
5
2
Taichun Qin
5
1
Jazmine N Brown
4
2
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 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
Batch production and control records do not include complete information relating to the production and control of each batch.
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: Media fill issues highlight core lapses in simulating real production conditions, directly impacting aseptic process validation.
Excerpt: Aseptic Process Simulation In-process fill checks involve passing a During media fills the is kept into the Grade A area, inside the barrier and the vials are holding the above the level...
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
Stokes Healthcare Inc. dba Epicur Pharma		 23 May 2025 Normal Justification: Media fill not reflective of actual conditions led to potential risks not being addressed during validation.
Excerpt: However, during routine production... media fill study...
View Details

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