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Sub System /
Contamination Control
Contamination Control
View Detailed Analysis

Analytics Overview

305
Form 483s Issued
47
483s converted to WL
615
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
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
View Form 483
05 May 2026
Zydus Lifesciences Limited
Drugs
View Form 483
08 Apr 2026
Pharmaneek Inc
Drugs
View Form 483
27 Mar 2026
Charles River Laboratories, Inc.
Drugs
View Form 483
27 Mar 2026
Fujifilm Diosynth Biotechnologies USA Inc.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
50
11
Anastasia M Shields
29
11
Taichun Qin
23
9
Sena G Dissmeyer
23
0
Brandy N Lepage
18
0

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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Contamination control directly impacts exposure management during aseptic processing as evidenced by inadequate handling.
Excerpt: The simulation shows the (b) (4) directly over exposed vials; however, no vials were removed.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Contamination Control is directly linked as it's pivotal to ensuring drug product sterility, which is compromised.
Excerpt: Residues and uneven surfaces in ISO 5 may lead to contamination of sterile drug products.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Zydus Lifesciences Limited		 05 May 2026 Normal Justification: Airflow is critical in contamination control within aseptic environments; lack of specifics can lead to product contamination.
Excerpt: The firm does not address air velocity working height specifications in the contamination control strategy.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Zydus Lifesciences Limited		 05 May 2026 Normal Justification: Contamination control flaws directly affect sterility assurance, critical for sterile drug products.
Excerpt: Your firm failed to implement and maintain controls to ensure the sterility of drug products.
View Details

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Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
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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

305
Form 483s Issued
47
483s converted to WL
615
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
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
View Form 483
05 May 2026
Zydus Lifesciences Limited
Drugs
View Form 483
08 Apr 2026
Pharmaneek Inc
Drugs
View Form 483
27 Mar 2026
Charles River Laboratories, Inc.
Drugs
View Form 483
27 Mar 2026
Fujifilm Diosynth Biotechnologies USA Inc.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
50
11
Anastasia M Shields
29
11
Taichun Qin
23
9
Sena G Dissmeyer
23
0
Brandy N Lepage
18
0

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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Contamination control directly impacts exposure management during aseptic processing as evidenced by inadequate handling.
Excerpt: The simulation shows the (b) (4) directly over exposed vials; however, no vials were removed.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
Emcure Pharmaceuticals Limited		 15 May 2026 Normal Justification: Contamination Control is directly linked as it's pivotal to ensuring drug product sterility, which is compromised.
Excerpt: Residues and uneven surfaces in ISO 5 may lead to contamination of sterile drug products.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Zydus Lifesciences Limited		 05 May 2026 Normal Justification: Airflow is critical in contamination control within aseptic environments; lack of specifics can lead to product contamination.
Excerpt: The firm does not address air velocity working height specifications in the contamination control strategy.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Zydus Lifesciences Limited		 05 May 2026 Normal Justification: Contamination control flaws directly affect sterility assurance, critical for sterile drug products.
Excerpt: Your firm failed to implement and maintain controls to ensure the sterility of drug products.
View Details

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