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Sub System /
Environmental Monitoring
Environmental Monitoring
View Detailed Analysis

Analytics Overview

233
Form 483s Issued
40
483s converted to WL
443
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
08 Apr 2026
Pharmaneek Inc
Drugs
27 Feb 2026
EUGIA Pharma Specialities Limited
Drugs
20 Feb 2026
Maiva Pharma Private Limited
Drugs
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
22 Jan 2026
Excel Vision
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
42
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
Your facility is not maintained in a good state of repair, creating insanitary conditions whereby drug products may be contaminated with filth.
Pharmaneek Inc
08 Apr 2026 Normal Justification: Environmental Monitoring is integral in ensuring that the control room environment remains free from contaminants that could affect product safety.
Excerpt: A ceiling tile in the control room was observed to be chipped, with part missing, exposing the room to environmental contaminants.
View 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 and followed.
EUGIA Pharma Specialities Limited
27 Feb 2026 Normal Justification: Environmental Monitoring is involved as the critical operation area failed to adhere to Grade A-No Growth standards.
Excerpt: The area is not held to Grade A classification during this critical operation.
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

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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

233
Form 483s Issued
40
483s converted to WL
443
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
08 Apr 2026
Pharmaneek Inc
Drugs
27 Feb 2026
EUGIA Pharma Specialities Limited
Drugs
20 Feb 2026
Maiva Pharma Private Limited
Drugs
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
22 Jan 2026
Excel Vision
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
42
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
Your facility is not maintained in a good state of repair, creating insanitary conditions whereby drug products may be contaminated with filth.
Pharmaneek Inc
08 Apr 2026 Normal Justification: Environmental Monitoring is integral in ensuring that the control room environment remains free from contaminants that could affect product safety.
Excerpt: A ceiling tile in the control room was observed to be chipped, with part missing, exposing the room to environmental contaminants.
View 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 and followed.
EUGIA Pharma Specialities Limited
27 Feb 2026 Normal Justification: Environmental Monitoring is involved as the critical operation area failed to adhere to Grade A-No Growth standards.
Excerpt: The area is not held to Grade A classification during this critical operation.
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

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