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Sub System /
Environmental Monitoring
Environmental Monitoring
View Detailed Analysis

Analytics Overview

188
Form 483s Issued
40
483s converted to WL
369
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 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
39
16
Anastasia M Shields
24
12
Jazmine N Brown
21
13
Camerson E Moore
18
3
Pratik S Upadhyay
15
4

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: The core issue is the absence of an environmental monitoring protocol, crucial for maintaining aseptic conditions.
Excerpt: Your firm has not performed any environmental monitoring during aseptic operation since you started manufacturing and releasing sterile drug products.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Environmental monitoring outside critical contact areas fails to assure sterility in aseptic processing.
Excerpt: EM sampling was performed outside of the operator's critical contact areas as defined by SOP 4.090.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Inadequate monitoring of environmental conditions directly relates to the Environmental Monitoring process type, affecting storage condition integrity.
Excerpt: No scientific justification for the placement of the probe used to measure temperature and humidity in the DEA cage.
View Details
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Environmental Monitoring is critical since poor construction impacts ability to monitor and control contamination levels.
Excerpt: "Ceiling Cassette" circulate air without HEPA filtration, your ISO 7 cleanrooms lacks air return capability.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the process
GenoGenix, LLC		 18 Jul 2025 Normal Justification: No smoke studies performed despite active manufacturing indicates neglect in monitoring and validation of cleanroom environments.
Excerpt: G. Your firm has not performed smoke studies in any of your (b) (4) ISO 5 BSCs.
View Details

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Go back

Environmental Monitoring

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

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Environmental Monitoring

Overview

188
Form 483s Issued
40
483s converted to WL
369
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 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
39
16
Anastasia M Shields
24
12
Jazmine N Brown
21
13
Camerson E Moore
18
3
Pratik S Upadhyay
15
4

Key Observations

TITLE/ COMPANY Issue Date Status Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: The core issue is the absence of an environmental monitoring protocol, crucial for maintaining aseptic conditions.
Excerpt: Your firm has not performed any environmental monitoring during aseptic operation since you started manufacturing and releasing sterile drug products.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Environmental monitoring outside critical contact areas fails to assure sterility in aseptic processing.
Excerpt: EM sampling was performed outside of the operator's critical contact areas as defined by SOP 4.090.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Inadequate monitoring of environmental conditions directly relates to the Environmental Monitoring process type, affecting storage condition integrity.
Excerpt: No scientific justification for the placement of the probe used to measure temperature and humidity in the DEA cage.
View Details
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Environmental Monitoring is critical since poor construction impacts ability to monitor and control contamination levels.
Excerpt: "Ceiling Cassette" circulate air without HEPA filtration, your ISO 7 cleanrooms lacks air return capability.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the process
GenoGenix, LLC		 18 Jul 2025 Normal Justification: No smoke studies performed despite active manufacturing indicates neglect in monitoring and validation of cleanroom environments.
Excerpt: G. Your firm has not performed smoke studies in any of your (b) (4) ISO 5 BSCs.
View Details

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