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Sub System /
Environmental Monitoring
Environmental Monitoring
View Detailed Analysis

Analytics Overview

192
Form 483s Issued
40
483s converted to WL
374
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
26 Sep 2025
Hetero Labs Limited (Warehouse)
Drugs
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs
18 Jul 2025
Right Value Drug Stores LLC
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
30
12
Anastasia M Shields
24
12
José E Melendez
21
9
Camerson E Moore
18
3
Jazmine N Brown
17
13
TITLE/ COMPANY Issue Date Status Details
Procedures describing the warehousing of APIs, Intermediates and raw materials are not established.
Hetero Labs Limited (Warehouse)
26 Sep 2025 Normal Justification: Temperature and humidity are mentioned as unmonitored in the storage description.
Excerpt: B) there is no system or mechanism for monitoring warehouse temperature and humidity for APIs.
View Details
The Quality Unit has not established adequate procedural controls and oversight
Dr. Reddy's Laboratories, LTD, Biologics
12 Sep 2025 Normal Justification: Environmental monitoring is directly challenged by the inaccuracies and discrepancies in data management.
Excerpt: Environmental monitoring data from data collection sheets are manually entered into uncontrolled electronic spreadsheets.
View Details
Aseptic processing area are deficient regarding the system for monitoring environmental conditions
Aurobindo Pharma Ltd.
05 Sep 2025 Normal Justification: Environmental monitoring directly relates to the observation which highlights deficiencies in monitoring processes.
Excerpt: lack of viable EM and non-viable particle count (NVPC) monitoring of the Grade A LAF in Line.
View Details
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
Aurobindo Pharma Ltd.
05 Sep 2025 Normal Justification: Environmental monitoring is impacted as standing water introduces potential contamination risks requiring regular assessments.
Excerpt: Puddles of water accumulated and a plastic bag collecting rainwater near entry doorways.
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

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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.

Environmental Monitoring

Overview

192
Form 483s Issued
40
483s converted to WL
374
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
26 Sep 2025
Hetero Labs Limited (Warehouse)
Drugs
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs
18 Jul 2025
Right Value Drug Stores LLC
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
30
12
Anastasia M Shields
24
12
José E Melendez
21
9
Camerson E Moore
18
3
Jazmine N Brown
17
13

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures describing the warehousing of APIs, Intermediates and raw materials are not established.
Hetero Labs Limited (Warehouse)
26 Sep 2025 Normal Justification: Temperature and humidity are mentioned as unmonitored in the storage description.
Excerpt: B) there is no system or mechanism for monitoring warehouse temperature and humidity for APIs.
View Details
The Quality Unit has not established adequate procedural controls and oversight
Dr. Reddy's Laboratories, LTD, Biologics
12 Sep 2025 Normal Justification: Environmental monitoring is directly challenged by the inaccuracies and discrepancies in data management.
Excerpt: Environmental monitoring data from data collection sheets are manually entered into uncontrolled electronic spreadsheets.
View Details
Aseptic processing area are deficient regarding the system for monitoring environmental conditions
Aurobindo Pharma Ltd.
05 Sep 2025 Normal Justification: Environmental monitoring directly relates to the observation which highlights deficiencies in monitoring processes.
Excerpt: lack of viable EM and non-viable particle count (NVPC) monitoring of the Grade A LAF in Line.
View Details
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
Aurobindo Pharma Ltd.
05 Sep 2025 Normal Justification: Environmental monitoring is impacted as standing water introduces potential contamination risks requiring regular assessments.
Excerpt: Puddles of water accumulated and a plastic bag collecting rainwater near entry doorways.
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

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