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Sub System /
Process Validation
Process Validation
View Detailed Analysis

Analytics Overview

121
Form 483s Issued
21
483s converted to WL
146
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
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
17
0
John Doe
17
0
Justin A Boyd
12
6
Anastasia M Shields
10
6
José E Melendez
9
3

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: The observation highlights a direct impact on process validation as it points out the need for a comprehensive risk assessment to ensure aseptic validation procedures are adequate.
Excerpt: Your firm did not provide a formal risk assessment that considers all potential contamination risk factors that could occur on the vial filling line.
View Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Fareva Amboise		 16 Sep 2025 Normal Justification: Process validation is necessary to confirm that operations can consistently produce products meeting quality requirements.
Excerpt: Process validation data has not been collected to establish acceptable ranges for compression machine setting.
View Details
Written documents are inadequate to ensure proper documentation and analysis of critical manufacturing operations
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: The observation shows a failure in ensuring process validation through comprehensive analysis, impacting sterility assurance.
Excerpt: Report VALRP-BTO-002395 failed to provide a comprehensive analysis of the smoke study videos.
View Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure...
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: Process validation ensures the manufacturing processes yield a product meeting its intended specifications. This observation highlights lapse in achieving this.
Excerpt: Process validations do not ensure critical parameters are challenged and validated ranges are not incorporated into batch records.
View Details
Your firm failed to establish adequate written procedures for production and process controls
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Observation highlights deficiencies in process validation, crucial for ensuring uniformity and compliance.
Excerpt: Process validation for the pellet products intended for implantation does not assess pellet-to-pellet content uniformity.
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.

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Process Validation

Overview

121
Form 483s Issued
21
483s converted to WL
146
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
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
View Form 483
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
17
0
John Doe
17
0
Justin A Boyd
12
6
Anastasia M Shields
10
6
José E Melendez
9
3

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products
Immacule Lifesciences Private Limited		 18 Sep 2025 Normal Justification: The observation highlights a direct impact on process validation as it points out the need for a comprehensive risk assessment to ensure aseptic validation procedures are adequate.
Excerpt: Your firm did not provide a formal risk assessment that considers all potential contamination risk factors that could occur on the vial filling line.
View Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Fareva Amboise		 16 Sep 2025 Normal Justification: Process validation is necessary to confirm that operations can consistently produce products meeting quality requirements.
Excerpt: Process validation data has not been collected to establish acceptable ranges for compression machine setting.
View Details
Written documents are inadequate to ensure proper documentation and analysis of critical manufacturing operations
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: The observation shows a failure in ensuring process validation through comprehensive analysis, impacting sterility assurance.
Excerpt: Report VALRP-BTO-002395 failed to provide a comprehensive analysis of the smoke study videos.
View Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure...
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: Process validation ensures the manufacturing processes yield a product meeting its intended specifications. This observation highlights lapse in achieving this.
Excerpt: Process validations do not ensure critical parameters are challenged and validated ranges are not incorporated into batch records.
View Details
Your firm failed to establish adequate written procedures for production and process controls
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Observation highlights deficiencies in process validation, crucial for ensuring uniformity and compliance.
Excerpt: Process validation for the pellet products intended for implantation does not assess pellet-to-pellet content uniformity.
View Details

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