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Sub System /
Contamination Control
Contamination Control
View Detailed Analysis

Analytics Overview

258
Form 483s Issued
47
483s converted to WL
529
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
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
48
11
Anastasia M Shields
27
11
Taichun Qin
23
9
Sena G Dissmeyer
22
0
José E Melendez
18
9

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: Contamination Control is crucial to preventing microbial growth in sterile processing, which is directly mentioned in observation part A.
Excerpt: The aseptic processing area had inadequate procedures for the prevention and detection of overgrowth of microbial contaminants during the lyophilization process.
View Details
Failure to establish and follow appropriate written procedures to prevent microbiological contamination of drug products purporting to be sterile
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation highlights failures leading to potential microbiological contamination due to undocumented interventions during aseptic processes.
Excerpt: Interventions not recorded include sensor adjustments, removal of fallen vials, stuck/jammed seal.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation outlines risks in personnel flow impacting contamination control, highlighting lapses in aseptic practices and area transitions.
Excerpt: There is no assurance that the current flow of personnel within the vial filling Lines is designed to prevent microbial contamination.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: The observation details lapses in sterile practices (e.g., contact with sterile equipment), directly implicating contamination control procedures.
Excerpt: Poor aseptic practices and inadequate glove monitoring were observed during review of CCTV recordings of sterile production.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Contamination control is critical in aseptic operations and interventions disruption in airflow can lead to contamination.
Excerpt: rely on a (b) (4) wait time for NVPC to return to normal without validated recovery times.
View Details

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Go back

Contamination Control

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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Contamination Control

Overview

258
Form 483s Issued
47
483s converted to WL
529
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
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
48
11
Anastasia M Shields
27
11
Taichun Qin
23
9
Sena G Dissmeyer
22
0
José E Melendez
18
9

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: Contamination Control is crucial to preventing microbial growth in sterile processing, which is directly mentioned in observation part A.
Excerpt: The aseptic processing area had inadequate procedures for the prevention and detection of overgrowth of microbial contaminants during the lyophilization process.
View Details
Failure to establish and follow appropriate written procedures to prevent microbiological contamination of drug products purporting to be sterile
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation highlights failures leading to potential microbiological contamination due to undocumented interventions during aseptic processes.
Excerpt: Interventions not recorded include sensor adjustments, removal of fallen vials, stuck/jammed seal.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation outlines risks in personnel flow impacting contamination control, highlighting lapses in aseptic practices and area transitions.
Excerpt: There is no assurance that the current flow of personnel within the vial filling Lines is designed to prevent microbial contamination.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: The observation details lapses in sterile practices (e.g., contact with sterile equipment), directly implicating contamination control procedures.
Excerpt: Poor aseptic practices and inadequate glove monitoring were observed during review of CCTV recordings of sterile production.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Contamination control is critical in aseptic operations and interventions disruption in airflow can lead to contamination.
Excerpt: rely on a (b) (4) wait time for NVPC to return to normal without validated recovery times.
View Details

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