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Sub System /
Contamination Control
Contamination Control
View Detailed Analysis

Analytics Overview

267
Form 483s Issued
47
483s converted to WL
522
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
16 Sep 2025
Fareva Amboise
Drugs
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
08 Aug 2025
AnazaoHealth Corporation
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
39
11
John Doe
32
0
Jane Smith
31
0
Anastasia M Shields
26
11
Taichun Qin
23
9
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Immacule Lifesciences Private Limited
18 Sep 2025 Normal Justification: The observation highlights ineffective contamination control practices, evidenced by improper sanitization and non-representative airflow studies.
Excerpt: When wiping with the sanitizing agent, blue marker ink smeared onto surface; inadequate airflow pattern studies recorded.
View Details
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components
Immacule Lifesciences Private Limited
18 Sep 2025 Normal Justification: Removal of key air sampling steps affects control over microbial contamination.
Excerpt: “...your firm eliminated the active air sampling before clearing the line for the assembly of machine parts...”
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions
Fareva Amboise
16 Sep 2025 Normal Justification: The observation points out failures in maintaining aseptic conditions and cleaning practices, which are directly linked to contamination control issues.
Excerpt: There is no routine use of a sporicidal agent on equipment surfaces inside your Grade A filling barrier.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Fareva Amboise
16 Sep 2025 Normal Justification: Contamination Control is crucial as operators' actions directly affected sterile conditions.
Excerpt: Operators reached under the barrier, transferred items without disinfection, and stored items improperly within Grade A areas.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Fareva Amboise
16 Sep 2025 Normal Justification: Inadequate airflow tests and aseptic validations are directly linked to Contamination Control issues.
Excerpt: The quality unit approved airflow smoke tests...did not include adequate validation of the aseptic process.
View Details

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Contamination Control

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

Contamination Control

Overview

267
Form 483s Issued
47
483s converted to WL
522
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
18 Sep 2025
Immacule Lifesciences Private Limited
Drugs
16 Sep 2025
Fareva Amboise
Drugs
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
08 Aug 2025
AnazaoHealth Corporation
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
39
11
John Doe
32
0
Jane Smith
31
0
Anastasia M Shields
26
11
Taichun Qin
23
9

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Immacule Lifesciences Private Limited
18 Sep 2025 Normal Justification: The observation highlights ineffective contamination control practices, evidenced by improper sanitization and non-representative airflow studies.
Excerpt: When wiping with the sanitizing agent, blue marker ink smeared onto surface; inadequate airflow pattern studies recorded.
View Details
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components
Immacule Lifesciences Private Limited
18 Sep 2025 Normal Justification: Removal of key air sampling steps affects control over microbial contamination.
Excerpt: “...your firm eliminated the active air sampling before clearing the line for the assembly of machine parts...”
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions
Fareva Amboise
16 Sep 2025 Normal Justification: The observation points out failures in maintaining aseptic conditions and cleaning practices, which are directly linked to contamination control issues.
Excerpt: There is no routine use of a sporicidal agent on equipment surfaces inside your Grade A filling barrier.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Fareva Amboise
16 Sep 2025 Normal Justification: Contamination Control is crucial as operators' actions directly affected sterile conditions.
Excerpt: Operators reached under the barrier, transferred items without disinfection, and stored items improperly within Grade A areas.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Fareva Amboise
16 Sep 2025 Normal Justification: Inadequate airflow tests and aseptic validations are directly linked to Contamination Control issues.
Excerpt: The quality unit approved airflow smoke tests...did not include adequate validation of the aseptic process.
View Details

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