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Sub System /
Contamination Control
Contamination Control
View Detailed Analysis

Analytics Overview

208
Form 483s Issued
35
483s converted to WL
447
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
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
46
13
Anastasia M Shields
26
11
Taichun Qin
23
7
Sena G Dissmeyer
22
0
Camerson E Moore
18
0

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 followed
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Smoke studies and personnel and environmental monitoring are critical in maintaining contamination control.
Excerpt: Your firm failed to perform smoke study videos of the BSCs in a dynamic state.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Contamination Control is linked as the SOP lacks instructions on sterilization, risking microbiological contamination of sterile products.
Excerpt: Specifically, the SOP allows the use of non-sterile to clean surfaces and lacks prohibition for non-sterile material introduction.
View Details
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Contamination control relies on regular needle changes to prevent particle generation, essential for drug safety.
Excerpt: Needle replacement is performed specifically to reduce potential black particles (likely rubber coring or metal particles).
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: The issue of microbiological contamination directly relates to contamination control, impacted by unqualified personnel and outdated procedures.
Excerpt: Your firm does not have any employees fully qualified to perform 100% visual inspection activities on sterile drug products.
View Details
Equipment and utensils are not maintained at appropriate intervals to prevent contamination
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: The observation highlights failures in maintaining controlled environments essential for contamination prevention in aseptic processing.
Excerpt: Damage on the wall above and below the clean room phone panel in the Grade A extended laminar airflow (LAF) area.
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.

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Contamination Control

Overview

208
Form 483s Issued
35
483s converted to WL
447
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
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
46
13
Anastasia M Shields
26
11
Taichun Qin
23
7
Sena G Dissmeyer
22
0
Camerson E Moore
18
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Smoke studies and personnel and environmental monitoring are critical in maintaining contamination control.
Excerpt: Your firm failed to perform smoke study videos of the BSCs in a dynamic state.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Contamination Control is linked as the SOP lacks instructions on sterilization, risking microbiological contamination of sterile products.
Excerpt: Specifically, the SOP allows the use of non-sterile to clean surfaces and lacks prohibition for non-sterile material introduction.
View Details
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: Contamination control relies on regular needle changes to prevent particle generation, essential for drug safety.
Excerpt: Needle replacement is performed specifically to reduce potential black particles (likely rubber coring or metal particles).
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: The issue of microbiological contamination directly relates to contamination control, impacted by unqualified personnel and outdated procedures.
Excerpt: Your firm does not have any employees fully qualified to perform 100% visual inspection activities on sterile drug products.
View Details
Equipment and utensils are not maintained at appropriate intervals to prevent contamination
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: The observation highlights failures in maintaining controlled environments essential for contamination prevention in aseptic processing.
Excerpt: Damage on the wall above and below the clean room phone panel in the Grade A extended laminar airflow (LAF) area.
View Details

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