Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST. Save Your Seat
Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST Save Your Seat
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Sub System /
Preventive Maintenance
Preventive Maintenance
View Detailed Analysis

Analytics Overview

44
Form 483s Issued
8
483s converted to WL
50
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
01 Aug 2025
Not available
Drugs
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
10 Apr 2025
Aurolige Pharma LLC
Drugs
20 Nov 2024
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
19 Nov 2024
Janssen Vaccines Corporation
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
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 manufacture of intermediates and APIs should be maintained in a good state of repair
Zhejiang Huahai Pharmaceutical Co., Ltd.
20 Nov 2024 Normal Justification: The observation directly states that preventive maintenance checks did not include inspections for material integrity, allowing degradation to go unaddressed.
Excerpt: Your firm's equipment preventive maintenance records (PMs) show that a preventive maintenance check was performed ... and this deficiency was not addressed.
View Details
The firm failed to establish and follow adequate written procedures for the cleaning and maintenance of equipment
Janssen Vaccines Corporation
19 Nov 2024 Normal Justification: Preventive maintenance ensures equipment remains fit for use; unexplained residues signal a failure in maintenance checks.
Excerpt: Maintenance records did not indicate any inspection or corrective action taken for the observed residues.
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

44
Form 483s Issued
8
483s converted to WL
50
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
01 Aug 2025
Not available
Drugs
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
10 Apr 2025
Aurolige Pharma LLC
Drugs
20 Nov 2024
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
19 Nov 2024
Janssen Vaccines Corporation
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
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 manufacture of intermediates and APIs should be maintained in a good state of repair
Zhejiang Huahai Pharmaceutical Co., Ltd.
20 Nov 2024 Normal Justification: The observation directly states that preventive maintenance checks did not include inspections for material integrity, allowing degradation to go unaddressed.
Excerpt: Your firm's equipment preventive maintenance records (PMs) show that a preventive maintenance check was performed ... and this deficiency was not addressed.
View Details
The firm failed to establish and follow adequate written procedures for the cleaning and maintenance of equipment
Janssen Vaccines Corporation
19 Nov 2024 Normal Justification: Preventive maintenance ensures equipment remains fit for use; unexplained residues signal a failure in maintenance checks.
Excerpt: Maintenance records did not indicate any inspection or corrective action taken for the observed residues.
View Details

Frequently Asked Questions

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