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Sub System /
Contamination Control
Contamination Control
View Detailed Analysis

Analytics Overview

221
Form 483s Issued
47
483s converted to WL
464
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
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
36
11
Anastasia M Shields
26
11
Taichun Qin
23
9
Sena G Dissmeyer
22
0
Camerson E Moore
18
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate aseptic techniques during aseptic filling setup for Batch No.
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: Observation highlights improper aseptic setup practices related to airflow blockage, impacting contamination control.
Excerpt: Precautions to reduce the potential block of first air were not followed during aseptic fill line setup.
View Details
The risk assessment for viral control at Dr. Reddy's Laboratories is inadequate
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: Contamination Control is linked due to the shared equipment and inadequate sanitization failing to manage contamination risks effectively.
Excerpt: While DP manufacturing utilizes dedicated product contact equipment, non-United States market DP share the same Restricted Access Barrier Systems.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: The observation highlights failures in aseptic processing controls, a core aspect of contamination control.
Excerpt: RABS design principle and purpose are not adequately followed to prevent potential microbial contamination.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Contamination risks during aseptic operations require stringent control procedures which were not adequately applied.
Excerpt: During aseptic operations, the innermost sterile packaging layer of stoppers was routinely briefly exposed to the ISO 7 environment.
View Details
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
Sumitomo Pharma Co., Ltd.		 07 Aug 2025 Normal Justification: The observation highlights a gap in the implementation of contamination control measures, critical for preventing objectionable microorganisms.
Excerpt: There is no documented microbial risk assessment to determine whether the microbial (b) (4) control strategy for the system is adequate.
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

221
Form 483s Issued
47
483s converted to WL
464
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
12 Sep 2025
Dr. Reddy's Laboratories, LTD, Biologics
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
36
11
Anastasia M Shields
26
11
Taichun Qin
23
9
Sena G Dissmeyer
22
0
Camerson E Moore
18
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate aseptic techniques during aseptic filling setup for Batch No.
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: Observation highlights improper aseptic setup practices related to airflow blockage, impacting contamination control.
Excerpt: Precautions to reduce the potential block of first air were not followed during aseptic fill line setup.
View Details
The risk assessment for viral control at Dr. Reddy's Laboratories is inadequate
Dr. Reddy's Laboratories, LTD, Biologics		 12 Sep 2025 Normal Justification: Contamination Control is linked due to the shared equipment and inadequate sanitization failing to manage contamination risks effectively.
Excerpt: While DP manufacturing utilizes dedicated product contact equipment, non-United States market DP share the same Restricted Access Barrier Systems.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: The observation highlights failures in aseptic processing controls, a core aspect of contamination control.
Excerpt: RABS design principle and purpose are not adequately followed to prevent potential microbial contamination.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Contamination risks during aseptic operations require stringent control procedures which were not adequately applied.
Excerpt: During aseptic operations, the innermost sterile packaging layer of stoppers was routinely briefly exposed to the ISO 7 environment.
View Details
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
Sumitomo Pharma Co., Ltd.		 07 Aug 2025 Normal Justification: The observation highlights a gap in the implementation of contamination control measures, critical for preventing objectionable microorganisms.
Excerpt: There is no documented microbial risk assessment to determine whether the microbial (b) (4) control strategy for the system is adequate.
View Details

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