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Sub System /
Media Fill
Media Fill
View Detailed Analysis

Analytics Overview

69
Form 483s Issued
18
483s converted to WL
80
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
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
26 Sep 2025
Baxter Onocology GmbH
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
Jazmine N Brown
4
3
Sena G Dissmeyer
4
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: The observation describes deficiencies in media fill processes, directly impacting the validity of aseptic operations.
Excerpt: Your firm's media fills...are not designed or executed in a manner that is representative of routine aseptic operations.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: The media fill investigation highlighted systemic deficiencies in microbial risk management.
Excerpt: System design does not ensure drainage, and stagnant (b)(4) areas were not fully identified.
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

69
Form 483s Issued
18
483s converted to WL
80
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
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
26 Sep 2025
Baxter Onocology GmbH
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
Jazmine N Brown
4
3
Sena G Dissmeyer
4
0

Key Observations

TITLE/ COMPANY Issue Date Status 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: The observation describes deficiencies in media fill processes, directly impacting the validity of aseptic operations.
Excerpt: Your firm's media fills...are not designed or executed in a manner that is representative of routine aseptic operations.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: The media fill investigation highlighted systemic deficiencies in microbial risk management.
Excerpt: System design does not ensure drainage, and stagnant (b)(4) areas were not fully identified.
View Details

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