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Sub System /
Environmental Monitoring
Environmental Monitoring
View Detailed Analysis

Analytics Overview

218
Form 483s Issued
40
483s converted to WL
418
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483
21 Nov 2025
Shilpa Medicare Limited
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
39
12
Anastasia M Shields
24
12
José E Melendez
21
9
Camerson E Moore
18
3
Jazmine N Brown
17
13

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: The issue relates directly to the environmental monitoring process where discrepancies between Observer and Reviewer data are not addressed.
Excerpt: The initial reading of microbial plates is performed by the 'Observer' and the secondary reading/verification is performed by the 'Reviewer'.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Environmental Monitoring directly impacted due to failures in monitoring practices and NVPC handling in aseptic areas.
Excerpt: Personnel involved in interventions during filling activities are not held to Grade A specifications.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Root causes for microbial excursions weren’t comprehensively supported by collected data, spotlighting flaws in environmental monitoring.
Excerpt: Excursions were attributed to handling issues unsupported by the investigation data.
View Details
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Movement and de-gowning procedures in ISO-classified areas impact environmental conditions crucial for sterile production.
Excerpt: Pharmacy technicians...de-gown completely...before exiting the sterile compounding area.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: The observation directly impacts the Environmental Monitoring process, affecting sterility assurance and compliance standards.
Excerpt: Your firm is not performing environmental or personnel monitoring in the classified areas each day that sterile drugs are produced.
View Details

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Uncover Trends: FDA Investigator profiles & Observations.
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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.

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Environmental Monitoring

Overview

218
Form 483s Issued
40
483s converted to WL
418
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483
21 Nov 2025
Shilpa Medicare Limited
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
39
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
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: The issue relates directly to the environmental monitoring process where discrepancies between Observer and Reviewer data are not addressed.
Excerpt: The initial reading of microbial plates is performed by the 'Observer' and the secondary reading/verification is performed by the 'Reviewer'.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Environmental Monitoring directly impacted due to failures in monitoring practices and NVPC handling in aseptic areas.
Excerpt: Personnel involved in interventions during filling activities are not held to Grade A specifications.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Root causes for microbial excursions weren’t comprehensively supported by collected data, spotlighting flaws in environmental monitoring.
Excerpt: Excursions were attributed to handling issues unsupported by the investigation data.
View Details
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Movement and de-gowning procedures in ISO-classified areas impact environmental conditions crucial for sterile production.
Excerpt: Pharmacy technicians...de-gown completely...before exiting the sterile compounding area.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: The observation directly impacts the Environmental Monitoring process, affecting sterility assurance and compliance standards.
Excerpt: Your firm is not performing environmental or personnel monitoring in the classified areas each day that sterile drugs are produced.
View Details

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