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Sub System /
Media Fill
Media Fill
View Detailed Analysis

Analytics Overview

70
Form 483s Issued
18
483s converted to WL
82
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
9
1
Taichun Qin
6
1
Tekalign Wondimu
5
2
Sena G Dissmeyer
4
0
Jazmine N Brown
4
3

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
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
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
There is a failure to thoroughly review any unexplained discrepancy
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: The observation highlights failure in handling and investigating media fill processes, directly impacting product sterility.
Excerpt: Your firm has continued to experience numerous media fill failures with visible particle contamination found to be present.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Media fill processes are compromised by the absence of environmental sampling, critical for evaluating aseptic conditions.
Excerpt: Your firm is not performing viable active air or nonviable air sampling during media fills.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: Media fill failures point directly to handling and procedural weaknesses, reflecting issues in media fill process controls.
Excerpt: Media fill failure investigation identified seven contaminated vials; interventions showed aseptic behavior issues.
View Details

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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

70
Form 483s Issued
18
483s converted to WL
82
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
9
1
Taichun Qin
6
1
Tekalign Wondimu
5
2
Sena G Dissmeyer
4
0
Jazmine N Brown
4
3

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
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
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
There is a failure to thoroughly review any unexplained discrepancy
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: The observation highlights failure in handling and investigating media fill processes, directly impacting product sterility.
Excerpt: Your firm has continued to experience numerous media fill failures with visible particle contamination found to be present.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Media fill processes are compromised by the absence of environmental sampling, critical for evaluating aseptic conditions.
Excerpt: Your firm is not performing viable active air or nonviable air sampling during media fills.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: Media fill failures point directly to handling and procedural weaknesses, reflecting issues in media fill process controls.
Excerpt: Media fill failure investigation identified seven contaminated vials; interventions showed aseptic behavior issues.
View Details

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