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Sub System /
Environmental Monitoring
Environmental Monitoring
View Detailed Analysis

Analytics Overview

182
Form 483s Issued
28
483s converted to WL
358
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
Right Value Drug Stores LLC
Drugs
19 Jun 2025
NATCO Pharma Limited
Drugs
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
29 Apr 2025
East Orange VA Medical Center
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
39
14
Anastasia M Shields
24
12
Jazmine N Brown
21
12
Camerson E Moore
18
0
Pratik S Upadhyay
15
3
TITLE/ COMPANY Issue Date Status 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
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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch
NATCO Pharma Limited
19 Jun 2025 Normal Justification: Environmental monitoring failures are linked to both inadequate investigations of new microorganisms and unperformed efficacy studies.
Excerpt: A. Your firm did not perform a disinfectant efficacy study when a new microorganism was identified during an OOS investigation.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
NATCO Pharma Limited
19 Jun 2025 Normal Justification: Environmental Monitoring is central to this issue due to discrepancies in monitoring non-viable particles and adherence to procedures.
Excerpt: Environmental monitoring for non-viable particles (NVP) during aseptic operations was found to be inadequate.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Sun Pharmaceutical Industries Ltd.
13 Jun 2025 Normal Justification: The inability of current monitoring systems to accurately capture critical contamination points indicates flaws in environmental monitoring practices.
Excerpt: Environmental monitoring personnel moved through the conveyor, compromising the aseptic zone.
View Details

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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

Environmental Monitoring

Overview

182
Form 483s Issued
28
483s converted to WL
358
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 Jul 2025
Right Value Drug Stores LLC
Drugs
19 Jun 2025
NATCO Pharma Limited
Drugs
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
29 Apr 2025
East Orange VA Medical Center
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
39
14
Anastasia M Shields
24
12
Jazmine N Brown
21
12
Camerson E Moore
18
0
Pratik S Upadhyay
15
3

Key Observations

TITLE/ COMPANY Issue Date Status 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
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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch
NATCO Pharma Limited
19 Jun 2025 Normal Justification: Environmental monitoring failures are linked to both inadequate investigations of new microorganisms and unperformed efficacy studies.
Excerpt: A. Your firm did not perform a disinfectant efficacy study when a new microorganism was identified during an OOS investigation.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
NATCO Pharma Limited
19 Jun 2025 Normal Justification: Environmental Monitoring is central to this issue due to discrepancies in monitoring non-viable particles and adherence to procedures.
Excerpt: Environmental monitoring for non-viable particles (NVP) during aseptic operations was found to be inadequate.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Sun Pharmaceutical Industries Ltd.
13 Jun 2025 Normal Justification: The inability of current monitoring systems to accurately capture critical contamination points indicates flaws in environmental monitoring practices.
Excerpt: Environmental monitoring personnel moved through the conveyor, compromising the aseptic zone.
View Details

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