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Sub System /
Preventive Maintenance
Preventive Maintenance
View Detailed Analysis

Analytics Overview

110
Form 483s Issued
8
483s converted to WL
125
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
17 Sep 2026
Ultragenyx Pharmaceutical Inc.
Drugs
22 Apr 2026
BioLife Plasma Services, L.P.
Drugs
10 Apr 2026
AstraZeneca AB
Drugs
03 Apr 2026
Conroe Welding Supply, Inc
Drugs
03 Apr 2026
Granules Pharmaceuticals Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Shuang Tang
8
0
Massoud Motamed
7
0
Pratik S Upadhyay
7
1
Holly Brevig
7
0
Lewis K Antwi
6
0
TITLE/ COMPANY Issue Date Status Details
Procedures for the maintenance of equipment used in the manufacture and testing of FAYUVI are not followed.
Ultragenyx Pharmaceutical Inc.
17 Sep 2026 Normal Justification: Preventive Maintenance is linked because the issue pertains directly to the failure to perform scheduled equipment maintenance.
Excerpt: Records indicate that the preventive maintenance for the autoclave (ID #AU-202) was not conducted according to the schedule.
View Details
Failure to maintain equipment used in the collection of blood and blood products in a clean and orderly manner
BioLife Plasma Services, L.P.
22 Apr 2026 Normal Justification: The issue is directly linked to Preventive Maintenance because the critical failure was related to the neglected PM tasks as per the manufacturer's guidelines.
Excerpt: I reviewed preventive maintenance (PM) records and found that the required maintenance for the apheresis devices had not been performed as specified in the device Operator's Manual.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
AstraZeneca AB
10 Apr 2026 Normal Justification: Failure to update the preventive maintenance program was directly linked to the deviation caused by equipment wear.
Excerpt: The preventative maintenance program was not updated to address the equipment wear condition that caused this deviation.
View Details
Buildings used in the holding of a drug product are not maintained in a good state of repair.
Granules Pharmaceuticals Inc.
03 Apr 2026 Normal Justification: Preventive maintenance should detect potential failures, but lacked depth in identifying issues here.
Excerpt: Preventive maintenance failed to detect the improper wiring.
View Details
Buildings used in the holding of a drug product are not maintained in a good state of repair.
Granules Pharmaceuticals Inc.
03 Apr 2026 Normal Justification: Preventive maintenance should detect potential failures, but lacked depth in identifying issues here.
Excerpt: Preventive maintenance failed to detect the improper wiring.
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

110
Form 483s Issued
8
483s converted to WL
125
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
17 Sep 2026
Ultragenyx Pharmaceutical Inc.
Drugs
22 Apr 2026
BioLife Plasma Services, L.P.
Drugs
10 Apr 2026
AstraZeneca AB
Drugs
03 Apr 2026
Conroe Welding Supply, Inc
Drugs
03 Apr 2026
Granules Pharmaceuticals Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Shuang Tang
8
0
Massoud Motamed
7
0
Pratik S Upadhyay
7
1
Holly Brevig
7
0
Lewis K Antwi
6
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures for the maintenance of equipment used in the manufacture and testing of FAYUVI are not followed.
Ultragenyx Pharmaceutical Inc.
17 Sep 2026 Normal Justification: Preventive Maintenance is linked because the issue pertains directly to the failure to perform scheduled equipment maintenance.
Excerpt: Records indicate that the preventive maintenance for the autoclave (ID #AU-202) was not conducted according to the schedule.
View Details
Failure to maintain equipment used in the collection of blood and blood products in a clean and orderly manner
BioLife Plasma Services, L.P.
22 Apr 2026 Normal Justification: The issue is directly linked to Preventive Maintenance because the critical failure was related to the neglected PM tasks as per the manufacturer's guidelines.
Excerpt: I reviewed preventive maintenance (PM) records and found that the required maintenance for the apheresis devices had not been performed as specified in the device Operator's Manual.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
AstraZeneca AB
10 Apr 2026 Normal Justification: Failure to update the preventive maintenance program was directly linked to the deviation caused by equipment wear.
Excerpt: The preventative maintenance program was not updated to address the equipment wear condition that caused this deviation.
View Details
Buildings used in the holding of a drug product are not maintained in a good state of repair.
Granules Pharmaceuticals Inc.
03 Apr 2026 Normal Justification: Preventive maintenance should detect potential failures, but lacked depth in identifying issues here.
Excerpt: Preventive maintenance failed to detect the improper wiring.
View Details
Buildings used in the holding of a drug product are not maintained in a good state of repair.
Granules Pharmaceuticals Inc.
03 Apr 2026 Normal Justification: Preventive maintenance should detect potential failures, but lacked depth in identifying issues here.
Excerpt: Preventive maintenance failed to detect the improper wiring.
View Details

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