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Sub System /
Process Validation
Process Validation
View Detailed Analysis

Analytics Overview

130
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
29 Jun 2026
Not available
Drugs
01 May 2026
Mixlab WI LLC
Drugs
20 Feb 2026
Maiva Pharma Private Limited
Drugs
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
22 Jan 2026
Excel Vision
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
LaiMing Lee
21
0
Christy Osgood
21
0
Kiya Hamilton
21
0
David Carlson
21
0
Li Wang
21
0
TITLE/ COMPANY Issue Date Status Details
OBJECTIVE 1e: The proposed commercial process and manufacturing batch record, including instructions
Not available
29 Jun 2026 Normal Justification: Process validation is essential for establishing the feasibility of manufacturing operations using scientifically justified data. The observation notes a lack of sufficient validation studies.
Excerpt: At a minimum, data from Stage I process validation should be available. Evaluate Stage I process validation development studies and knowledge gained.
View Details
OBJECTIVE 2: Conformance to Application
Not available
29 Jun 2026 Normal Justification: Validated processes must reflect application details to ensure product efficacy and safety.
Excerpt: Verify that the manufacturing or processing methods are consistent with descriptions contained in the CMC section.
View Details
Drug Quality Violations: Current Good Manufacturing Practice Violations
Mixlab WI LLC
01 May 2026 Normal Justification: Process validation is essential due to the lack of validated processes ensuring each unit meets strength, quality, and purity requirements.
Excerpt: You do not use a validated production process to ensure each individual unit meets strength, quality, and purity requirements.
View Details
Failure to establish and follow appropriate written procedures to prevent microbiological contamination of drug products purporting to be sterile
Maiva Pharma Private Limited
20 Feb 2026 Normal Justification: Observation identifies inadequacies in simulating actual operating conditions for validation purposes.
Excerpt: Simulations do not reflect actual commercial manufacturing conditions and interventions.
View 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

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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

130
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
29 Jun 2026
Not available
Drugs
01 May 2026
Mixlab WI LLC
Drugs
20 Feb 2026
Maiva Pharma Private Limited
Drugs
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
22 Jan 2026
Excel Vision
Drugs

Top FDA Investigators

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

Key Observations

TITLE/ COMPANY Issue Date Status Details
OBJECTIVE 1e: The proposed commercial process and manufacturing batch record, including instructions
Not available
29 Jun 2026 Normal Justification: Process validation is essential for establishing the feasibility of manufacturing operations using scientifically justified data. The observation notes a lack of sufficient validation studies.
Excerpt: At a minimum, data from Stage I process validation should be available. Evaluate Stage I process validation development studies and knowledge gained.
View Details
OBJECTIVE 2: Conformance to Application
Not available
29 Jun 2026 Normal Justification: Validated processes must reflect application details to ensure product efficacy and safety.
Excerpt: Verify that the manufacturing or processing methods are consistent with descriptions contained in the CMC section.
View Details
Drug Quality Violations: Current Good Manufacturing Practice Violations
Mixlab WI LLC
01 May 2026 Normal Justification: Process validation is essential due to the lack of validated processes ensuring each unit meets strength, quality, and purity requirements.
Excerpt: You do not use a validated production process to ensure each individual unit meets strength, quality, and purity requirements.
View Details
Failure to establish and follow appropriate written procedures to prevent microbiological contamination of drug products purporting to be sterile
Maiva Pharma Private Limited
20 Feb 2026 Normal Justification: Observation identifies inadequacies in simulating actual operating conditions for validation purposes.
Excerpt: Simulations do not reflect actual commercial manufacturing conditions and interventions.
View 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

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Related Resources

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