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Sub System /
Environmental Monitoring
Environmental Monitoring
View Detailed Analysis

Analytics Overview

223
Form 483s Issued
40
483s converted to WL
429
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
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
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Grifols Diagnostic Solutions		 13 Mar 2026 Normal Justification: Environmental Monitoring is directly linked to detecting contamination, mentioned in observation part B.
Excerpt: The environmental monitoring program was inadequate in identifying and acting on potential sources of contamination in the aseptic processing area.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Environmental Monitoring is linked as it is crucial to ensure sterile conditions which are affected by AHU performance.
Excerpt: Failure to establish adequate procedural controls for AHU shutdown and restart may result in loss of pressure cascade ...
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Inadequate environmental controls identified highlight deficiencies specifically in Environmental Monitoring protocols.
Excerpt: Your firm failed to provide a scientific rationale for performing environmental monitoring under either static or dynamic conditions without defined criteria.
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
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

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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

223
Form 483s Issued
40
483s converted to WL
429
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
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
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Grifols Diagnostic Solutions		 13 Mar 2026 Normal Justification: Environmental Monitoring is directly linked to detecting contamination, mentioned in observation part B.
Excerpt: The environmental monitoring program was inadequate in identifying and acting on potential sources of contamination in the aseptic processing area.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Environmental Monitoring is linked as it is crucial to ensure sterile conditions which are affected by AHU performance.
Excerpt: Failure to establish adequate procedural controls for AHU shutdown and restart may result in loss of pressure cascade ...
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Inadequate environmental controls identified highlight deficiencies specifically in Environmental Monitoring protocols.
Excerpt: Your firm failed to provide a scientific rationale for performing environmental monitoring under either static or dynamic conditions without defined criteria.
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
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

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