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Sub System /
Contamination Control
Contamination Control
View Detailed Analysis

Analytics Overview

215
Form 483s Issued
47
483s converted to WL
456
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
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
46
16
Anastasia M Shields
26
11
Taichun Qin
24
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 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
Personnel practices within the facility do not adequately prevent microbial contamination of drug product.
Not available		 01 Aug 2025 Normal Justification: Contamination Control directly affects microbial contamination risks through personnel practices, as detailed in the observation.
Excerpt: Personnel gowns were noted to be in direct contact with these chair surfaces. Hair follicles and skin flakes were present...
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 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
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

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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

215
Form 483s Issued
47
483s converted to WL
456
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
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
46
16
Anastasia M Shields
26
11
Taichun Qin
24
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 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
Personnel practices within the facility do not adequately prevent microbial contamination of drug product.
Not available		 01 Aug 2025 Normal Justification: Contamination Control directly affects microbial contamination risks through personnel practices, as detailed in the observation.
Excerpt: Personnel gowns were noted to be in direct contact with these chair surfaces. Hair follicles and skin flakes were present...
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 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
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

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