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Sub System /
Preventive Maintenance
Preventive Maintenance
View Detailed Analysis

Analytics Overview

57
Form 483s Issued
8
483s converted to WL
64
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
28 Oct 2025
Lonza Visp
Drugs
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
03 Sep 2025
Biocon Biologics Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
7
1
Rafeeq Habeeb
5
0
Jane Smith
3
0
John Doe
3
0
Justin A Boyd
3
0
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Maiva Pharma Private Limited
20 Feb 2026 Normal Justification: Preventive Maintenance is involved as it directly pertains to the maintenance of AHUs which affects pressure differentials.
Excerpt: Your firm has not established and followed adequate written procedures to ensure maintenance of appropriate pressure differentials and airflow patterns during shutdown ...
View Details
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.
Aurobindo Pharma Limited, Unit VII
10 Feb 2026 Normal Justification: The lack of preventive maintenance attention directly connects to the Preventive Maintenance process type issues.
Excerpt: SOP No.: FU7-EN-MNP-007... has no mention of Quality Unit responsibilities...
View Details
Critical material used to manufacture is not tracked, maintained, or replaced throughout their lifetime
Lonza Visp
28 Oct 2025 Normal Justification: Preventive Maintenance is implicated due to the absence of routine checks leading to reactive repairs.
Excerpt: The product contact part of the (b)(4) is replaced; however, maintenance of the (b)(4) remains failure-based.
View 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
Written sanitation and facility maintenance procedures are not established or followed
Biocon Biologics Limited
03 Sep 2025 Normal Justification: The lack of written notification or investigation into leaks is a clear Preventive Maintenance failure.
Excerpt: No written notification or investigation into the leak until the current inspection.
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

57
Form 483s Issued
8
483s converted to WL
64
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
28 Oct 2025
Lonza Visp
Drugs
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
03 Sep 2025
Biocon Biologics Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
7
1
Rafeeq Habeeb
5
0
Jane Smith
3
0
John Doe
3
0
Justin A Boyd
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Maiva Pharma Private Limited
20 Feb 2026 Normal Justification: Preventive Maintenance is involved as it directly pertains to the maintenance of AHUs which affects pressure differentials.
Excerpt: Your firm has not established and followed adequate written procedures to ensure maintenance of appropriate pressure differentials and airflow patterns during shutdown ...
View Details
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.
Aurobindo Pharma Limited, Unit VII
10 Feb 2026 Normal Justification: The lack of preventive maintenance attention directly connects to the Preventive Maintenance process type issues.
Excerpt: SOP No.: FU7-EN-MNP-007... has no mention of Quality Unit responsibilities...
View Details
Critical material used to manufacture is not tracked, maintained, or replaced throughout their lifetime
Lonza Visp
28 Oct 2025 Normal Justification: Preventive Maintenance is implicated due to the absence of routine checks leading to reactive repairs.
Excerpt: The product contact part of the (b)(4) is replaced; however, maintenance of the (b)(4) remains failure-based.
View 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
Written sanitation and facility maintenance procedures are not established or followed
Biocon Biologics Limited
03 Sep 2025 Normal Justification: The lack of written notification or investigation into leaks is a clear Preventive Maintenance failure.
Excerpt: No written notification or investigation into the leak until the current inspection.
View Details

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Related Resources

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