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Sub System /
Contamination Control
Contamination Control
View Detailed Analysis

Analytics Overview

272
Form 483s Issued
47
483s converted to WL
554
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
29 Jun 2026
Not available
Drugs
View Form 483
08 Apr 2026
Pharmaneek Inc
Drugs
View Form 483
27 Feb 2026
EUGIA Pharma Specialities Limited
Drugs
View Form 483
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
50
11
Anastasia M Shields
27
11
Sena G Dissmeyer
23
0
Taichun Qin
23
9
Camerson E Moore
18
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Sufficient facility and equipment controls are in place to prevent contamination of and by the application product
Not available		 29 Jun 2026 Normal Justification: Contamination control is vital for ensuring product integrity, particularly when manufacturing potent products.
Excerpt: Verify that the establishment has facility, equipment cleaning, maintenance, and utility system controls in place.
View Details
Hazardous drugs were produced without providing adequate containment
Pharmaneek Inc		 08 Apr 2026 Normal Justification: Contamination Control is crucial as improper cleaning and shared utensil use heighten cross-contamination risks.
Excerpt: no deactivating agent is currently employed to ensure the inactivation and removal of hazardous drug residue.
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: 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
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: Contamination Control is critical as the observation highlights lapses in maintaining sterile environments and personnel aseptic technique.
Excerpt: Environmental and personnel monitoring within the Line(b) LAF are not appropriately established.
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

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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

272
Form 483s Issued
47
483s converted to WL
554
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
29 Jun 2026
Not available
Drugs
View Form 483
08 Apr 2026
Pharmaneek Inc
Drugs
View Form 483
27 Feb 2026
EUGIA Pharma Specialities Limited
Drugs
View Form 483
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
50
11
Anastasia M Shields
27
11
Sena G Dissmeyer
23
0
Taichun Qin
23
9
Camerson E Moore
18
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Sufficient facility and equipment controls are in place to prevent contamination of and by the application product
Not available		 29 Jun 2026 Normal Justification: Contamination control is vital for ensuring product integrity, particularly when manufacturing potent products.
Excerpt: Verify that the establishment has facility, equipment cleaning, maintenance, and utility system controls in place.
View Details
Hazardous drugs were produced without providing adequate containment
Pharmaneek Inc		 08 Apr 2026 Normal Justification: Contamination Control is crucial as improper cleaning and shared utensil use heighten cross-contamination risks.
Excerpt: no deactivating agent is currently employed to ensure the inactivation and removal of hazardous drug residue.
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: 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
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: Contamination Control is critical as the observation highlights lapses in maintaining sterile environments and personnel aseptic technique.
Excerpt: Environmental and personnel monitoring within the Line(b) LAF are not appropriately established.
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

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