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Sub System /
Preventive Maintenance
Preventive Maintenance
View Detailed Analysis

Analytics Overview

173
Form 483s Issued
8
483s converted to WL
186
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
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
31 May 2025
Alembic Pharmaceuticals Limited (Units I and II)
Drugs
09 May 2025
Apotex Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
91
0
John Doe
90
0
John Smith
26
0
Jane Doe
23
0
Pratik S Upadhyay
7
1
TITLE/ COMPANY Issue Date Status Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and of adequate size
FARMAKEIO OUTSOURCING LLC
05 Sep 2025 Normal Justification: Preventive maintenance inadequacies can lead to equipment malfunction, causing product contamination risks.
Excerpt: Your firm failed to include in the PM an inspection of the impeller shaft...
View 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 is not cleaned and maintained to prevent contamination
Alembic Pharmaceuticals Limited (Units I and II)
31 May 2025 Normal Justification: Preventive maintenance failed to identify and correct issues, leading to quality risks.
Excerpt: Severity of damage underreported; no mention of dent marks, corrosion in maintenance report.
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.

Preventive Maintenance

Overview

173
Form 483s Issued
8
483s converted to WL
186
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
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
31 May 2025
Alembic Pharmaceuticals Limited (Units I and II)
Drugs
09 May 2025
Apotex Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
91
0
John Doe
90
0
John Smith
26
0
Jane Doe
23
0
Pratik S Upadhyay
7
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and of adequate size
FARMAKEIO OUTSOURCING LLC
05 Sep 2025 Normal Justification: Preventive maintenance inadequacies can lead to equipment malfunction, causing product contamination risks.
Excerpt: Your firm failed to include in the PM an inspection of the impeller shaft...
View 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 is not cleaned and maintained to prevent contamination
Alembic Pharmaceuticals Limited (Units I and II)
31 May 2025 Normal Justification: Preventive maintenance failed to identify and correct issues, leading to quality risks.
Excerpt: Severity of damage underreported; no mention of dent marks, corrosion in maintenance report.
View Details

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Related Resources

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