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Sub System /
Preventive Maintenance
Preventive Maintenance
View Detailed Analysis

Analytics Overview

45
Form 483s Issued
8
483s converted to WL
52
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 Aug 2025
Cohance Lifesciences Limited
Drugs
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
10 Apr 2025
Aurolige Pharma LLC
Drugs
17 Jan 2025
Genzyme Ireland Limited
Drugs
20 Nov 2024
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
7
1
Rafeeq A Habeeb
5
0
Alan L Truong
4
0
Jacob G Lutz
4
0
Justin A Boyd
4
1
TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: Observations of physical damage (cracks, dents) indicate negligence in Preventive Maintenance.
Excerpt: Visible dents on compression machine...large cracks within Tablets/Capsule Counting Machine.
View Details
Your firm fails to assure that the water system used in production areas provides consistent and uncontaminated water for API synthesis.
Not available
01 Aug 2025 Normal Justification: Neglect in maintaining the reverse osmosis system compromises the system's effectiveness and reliability.
Excerpt: No preventative maintenance schedule or routine monitoring log available for the reverse osmosis system.
View Details
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination
Sun Pharmaceutical Industries Ltd.
13 Jun 2025 Normal Justification: The issue stems from failing to maintain equipment, which is directly tied to preventive maintenance neglect.
Excerpt: The sealant that covered the cracks at the leaking areas appeared broken and missing sealant.
View Details
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination
Aurolige Pharma LLC
10 Apr 2025 Normal Justification: The lack of documentation following maintenance directly affects the cleaning process effectiveness, tied to Preventive Maintenance.
Excerpt: No cleaning action was recorded in the Log Book following the preventive maintenance.
View Details
Equipment used in the QC Microbiological Lab is not adequately maintained
Genzyme Ireland Limited
17 Jan 2025 Normal Justification: Preventive Maintenance is critical to ensure equipment is kept in a condition suitable for its intended use, as evidenced by the rust observed.
Excerpt: Laminar Flow Hood LAF used in in-process control bioburden testing was observed with the HEPA filter screen discolored
View Details

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Preventive Maintenance

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

Preventive Maintenance

Overview

45
Form 483s Issued
8
483s converted to WL
52
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
12 Aug 2025
Cohance Lifesciences Limited
Drugs
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
10 Apr 2025
Aurolige Pharma LLC
Drugs
17 Jan 2025
Genzyme Ireland Limited
Drugs
20 Nov 2024
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
7
1
Rafeeq A Habeeb
5
0
Alan L Truong
4
0
Jacob G Lutz
4
0
Justin A Boyd
4
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: Observations of physical damage (cracks, dents) indicate negligence in Preventive Maintenance.
Excerpt: Visible dents on compression machine...large cracks within Tablets/Capsule Counting Machine.
View Details
Your firm fails to assure that the water system used in production areas provides consistent and uncontaminated water for API synthesis.
Not available
01 Aug 2025 Normal Justification: Neglect in maintaining the reverse osmosis system compromises the system's effectiveness and reliability.
Excerpt: No preventative maintenance schedule or routine monitoring log available for the reverse osmosis system.
View Details
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination
Sun Pharmaceutical Industries Ltd.
13 Jun 2025 Normal Justification: The issue stems from failing to maintain equipment, which is directly tied to preventive maintenance neglect.
Excerpt: The sealant that covered the cracks at the leaking areas appeared broken and missing sealant.
View Details
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination
Aurolige Pharma LLC
10 Apr 2025 Normal Justification: The lack of documentation following maintenance directly affects the cleaning process effectiveness, tied to Preventive Maintenance.
Excerpt: No cleaning action was recorded in the Log Book following the preventive maintenance.
View Details
Equipment used in the QC Microbiological Lab is not adequately maintained
Genzyme Ireland Limited
17 Jan 2025 Normal Justification: Preventive Maintenance is critical to ensure equipment is kept in a condition suitable for its intended use, as evidenced by the rust observed.
Excerpt: Laminar Flow Hood LAF used in in-process control bioburden testing was observed with the HEPA filter screen discolored
View Details

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