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Sub System /
Process Validation
Process Validation
View Detailed Analysis

Analytics Overview

115
Form 483s Issued
21
483s converted to WL
163
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
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs
21 Nov 2025
Shilpa Medicare Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
21
0
LaiMing Lee
21
0
Christy Osgood
21
0
David Carlson
21
0
Li Wang
21
0
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: Process validation is pivotal in ensuring aseptic processes meet predefined standards during production.
Excerpt: do not demonstrate there is appropriate air laminarity during commercial operation.
View Details
Procedures designed to prevent microbiological contamination of drug products
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
19 Dec 2025 Normal Justification: The observation highlights a failure in simulating actual production conditions, indicating a process validation issue.
Excerpt: Media fills or aseptic process simulations performed do not closely simulate actual production conditions or cover worst case conditions.
View Details
The final and intermediate containers/closures used for drug product intended to be sterile have not been sterilized or depyrogenated.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
19 Dec 2025 Normal Justification: Process validation is critical to ensuring each sterilization cycle meets quality standards and regulatory compliance.
Excerpt: Your firm has not validated the re-sterilization process and has no procedure or process for tracking the number of sterilization cycles for (b) (4) stoppers.
View Details
Control procedures are not established which validate the performance of those manufacturing processes
Dr. Reddy's Laboratories Limited
12 Dec 2025 Normal Justification: Process Validation is required to confirm that manufacturing changes do not affect product quality.
Excerpt: Control procedures are not established which validate the performance of those manufacturing processes.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation
Shilpa Medicare Limited
21 Nov 2025 Normal Justification: Process validation linked to observation through inadequate aseptic process and requalification procedures.
Excerpt: Your firm's written procedure for requalification does not include sufficient detail for consistent replication of worst-case challenge conditions.
View Details

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Process Validation

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Process Validation

Overview

115
Form 483s Issued
21
483s converted to WL
163
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs
21 Nov 2025
Shilpa Medicare Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
21
0
LaiMing Lee
21
0
Christy Osgood
21
0
David Carlson
21
0
Li Wang
21
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: Process validation is pivotal in ensuring aseptic processes meet predefined standards during production.
Excerpt: do not demonstrate there is appropriate air laminarity during commercial operation.
View Details
Procedures designed to prevent microbiological contamination of drug products
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
19 Dec 2025 Normal Justification: The observation highlights a failure in simulating actual production conditions, indicating a process validation issue.
Excerpt: Media fills or aseptic process simulations performed do not closely simulate actual production conditions or cover worst case conditions.
View Details
The final and intermediate containers/closures used for drug product intended to be sterile have not been sterilized or depyrogenated.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
19 Dec 2025 Normal Justification: Process validation is critical to ensuring each sterilization cycle meets quality standards and regulatory compliance.
Excerpt: Your firm has not validated the re-sterilization process and has no procedure or process for tracking the number of sterilization cycles for (b) (4) stoppers.
View Details
Control procedures are not established which validate the performance of those manufacturing processes
Dr. Reddy's Laboratories Limited
12 Dec 2025 Normal Justification: Process Validation is required to confirm that manufacturing changes do not affect product quality.
Excerpt: Control procedures are not established which validate the performance of those manufacturing processes.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation
Shilpa Medicare Limited
21 Nov 2025 Normal Justification: Process validation linked to observation through inadequate aseptic process and requalification procedures.
Excerpt: Your firm's written procedure for requalification does not include sufficient detail for consistent replication of worst-case challenge conditions.
View Details

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