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Sub System /
Environmental Monitoring
Environmental Monitoring
View Detailed Analysis

Analytics Overview

256
Form 483s Issued
40
483s converted to WL
476
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
17 Sep 2026
Ultragenyx Pharmaceutical Inc.
Drugs
03 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
05 May 2026
Zydus Lifesciences Limited
Drugs
08 Apr 2026
Pharmaneek Inc
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
42
12
Anastasia M Shields
26
12
José E Melendez
21
9
Camerson E Moore
18
3
Jazmine N Brown
17
13
TITLE/ COMPANY Issue Date Status Details
Quality control testing is inadequate in that the laboratory records did not include complete data
Ultragenyx Pharmaceutical Inc.
17 Sep 2026 Normal Justification: Environmental monitoring is directly linked as it ensures sterile conditions necessary for aseptic processing.
Excerpt: The quality control laboratory failed to perform the required environmental monitoring during the aseptic filling process.
View Details
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: The environmental monitoring process requires reliable equipment operation to ensure sample integrity and accurate data collection.
Excerpt: Incubators and refrigerators used for product storage and EM sample incubation were not temperature mapped under loaded conditions.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Successful environmental monitoring is essential to ensure adequacy of aseptic conditions, which were deficient.
Excerpt: In all three August 2025 video records covering both LFH and LFH no active air sampling was performed concurrent with the AFV studies.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Monitoring fails to provide adequate assurance of environmental control over the entire operation.
Excerpt: The firm’s environmental monitoring program is inadequate.
View Details
Appropriate controls are not exercised over computers or related systems
Zydus Lifesciences Limited
05 May 2026 Normal Justification: The process type of Environmental Monitoring is implicated as electronic data is not reviewed before batch release.
Excerpt: Additionally, total air particulate environmental monitoring electronic data is not reviewed by Quality Assurance.
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

256
Form 483s Issued
40
483s converted to WL
476
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
17 Sep 2026
Ultragenyx Pharmaceutical Inc.
Drugs
03 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
05 May 2026
Zydus Lifesciences Limited
Drugs
08 Apr 2026
Pharmaneek Inc
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
42
12
Anastasia M Shields
26
12
José E Melendez
21
9
Camerson E Moore
18
3
Jazmine N Brown
17
13

Key Observations

TITLE/ COMPANY Issue Date Status Details
Quality control testing is inadequate in that the laboratory records did not include complete data
Ultragenyx Pharmaceutical Inc.
17 Sep 2026 Normal Justification: Environmental monitoring is directly linked as it ensures sterile conditions necessary for aseptic processing.
Excerpt: The quality control laboratory failed to perform the required environmental monitoring during the aseptic filling process.
View Details
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: The environmental monitoring process requires reliable equipment operation to ensure sample integrity and accurate data collection.
Excerpt: Incubators and refrigerators used for product storage and EM sample incubation were not temperature mapped under loaded conditions.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Successful environmental monitoring is essential to ensure adequacy of aseptic conditions, which were deficient.
Excerpt: In all three August 2025 video records covering both LFH and LFH no active air sampling was performed concurrent with the AFV studies.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Monitoring fails to provide adequate assurance of environmental control over the entire operation.
Excerpt: The firm’s environmental monitoring program is inadequate.
View Details
Appropriate controls are not exercised over computers or related systems
Zydus Lifesciences Limited
05 May 2026 Normal Justification: The process type of Environmental Monitoring is implicated as electronic data is not reviewed before batch release.
Excerpt: Additionally, total air particulate environmental monitoring electronic data is not reviewed by Quality Assurance.
View Details

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