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Sub System /
Alarm Management
Alarm Management
View Detailed Analysis

Analytics Overview

9
Form 483s Issued
1
483s converted to WL
11
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 Feb 2025
Piramal Pharma Limited
Drugs
View Form 483
07 Jun 2024
Frederick Manufacturing Center
Drugs
View Form 483
12 Apr 2024
Taenaka Kogyo Co., Ltd.
Drugs
View Form 483
04 Apr 2024
Cipla Limited
Drugs
View Form 483
18 Oct 2023
NATCO Pharma Limited
Drugs
View Form 483
View Warning Letter

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Liqun Zhao
2
0
Christina Farris
2
0
Christopher R Czajka
2
0
Kristen Nickens
2
0
Vidya Pai
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Piramal Pharma Limited		 17 Feb 2025 Normal Justification: Multiple alarms went unacknowledged, contrary to standard operating procedures and vendor instructions that mandated immediate action.
Excerpt: There was no investigation or documented explanation as to why the alarms remained present and unacknowledged for multiple hours.
View Details
Procedures in support of manufacture and the QC test laboratory are deficient
Frederick Manufacturing Center		 07 Jun 2024 Normal Justification: Unmonitored temperature alarms pose a risk to sample integrity and overall laboratory quality control.
Excerpt: We observed numerous controlled temperature units (CTU) in varying alarm conditions.
View Details
On 06 June 2024, we observed within the Quality Control Laboratory, numerous controlled temperature units (CTU) in varying alarm conditions.
Frederick Manufacturing Center		 07 Jun 2024 Normal Justification: Alarm Management is directly relevant since the observed issue is the failure to recognize and respond to alarm conditions in CTUs, which could negatively impact sample storage conditions.
Excerpt: You fail to have a procedure for routine inspection of CTU units.
View Details
Ventilation systems, including equipment for control of air pressure, are not adequately designed and constructed to minimize risks of contamination.
Taenaka Kogyo Co., Ltd.		 12 Apr 2024 Normal Justification: Alarm systems are critical for timely alerting personnel to address pressure excursions and prevent contamination.
Excerpt: The monitoring devices used to ensure the differential pressure between the production suites and the neighboring outside environment are not equipped with alarm systems to alert personnel to pressure excursions.
View Details
Facilities for the storage of materials under controlled temperature and humidity conditions are not sufficiently monitored
Taenaka Kogyo Co., Ltd.		 12 Apr 2024 Normal Justification: Observation shows that alarms are not effectively managed, risking unaddressed temperature excursions.
Excerpt: The alarm systems installed on such units throughout your facilities are configured to send email notifications to your Quality Control (QC) Manager, QC Test Manager, and Analytical Equipment Manager in the event one or more of the chambers experiences a temperature excursion.
View Details

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Go back

Alarm Management

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
Share

Alarm Management

Overview

9
Form 483s Issued
1
483s converted to WL
11
Total Observation
Form 483s Issued
+74 from last period

FDA Trends

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
17 Feb 2025
Piramal Pharma Limited
Drugs
View Form 483
07 Jun 2024
Frederick Manufacturing Center
Drugs
View Form 483
12 Apr 2024
Taenaka Kogyo Co., Ltd.
Drugs
View Form 483
04 Apr 2024
Cipla Limited
Drugs
View Form 483
18 Oct 2023
NATCO Pharma Limited
Drugs
View Form 483
View Warning Letter

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Liqun Zhao
2
0
Christina Farris
2
0
Christopher R Czajka
2
0
Kristen Nickens
2
0
Vidya Pai
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Piramal Pharma Limited		 17 Feb 2025 Normal Justification: Multiple alarms went unacknowledged, contrary to standard operating procedures and vendor instructions that mandated immediate action.
Excerpt: There was no investigation or documented explanation as to why the alarms remained present and unacknowledged for multiple hours.
View Details
Procedures in support of manufacture and the QC test laboratory are deficient
Frederick Manufacturing Center		 07 Jun 2024 Normal Justification: Unmonitored temperature alarms pose a risk to sample integrity and overall laboratory quality control.
Excerpt: We observed numerous controlled temperature units (CTU) in varying alarm conditions.
View Details
On 06 June 2024, we observed within the Quality Control Laboratory, numerous controlled temperature units (CTU) in varying alarm conditions.
Frederick Manufacturing Center		 07 Jun 2024 Normal Justification: Alarm Management is directly relevant since the observed issue is the failure to recognize and respond to alarm conditions in CTUs, which could negatively impact sample storage conditions.
Excerpt: You fail to have a procedure for routine inspection of CTU units.
View Details
Ventilation systems, including equipment for control of air pressure, are not adequately designed and constructed to minimize risks of contamination.
Taenaka Kogyo Co., Ltd.		 12 Apr 2024 Normal Justification: Alarm systems are critical for timely alerting personnel to address pressure excursions and prevent contamination.
Excerpt: The monitoring devices used to ensure the differential pressure between the production suites and the neighboring outside environment are not equipped with alarm systems to alert personnel to pressure excursions.
View Details
Facilities for the storage of materials under controlled temperature and humidity conditions are not sufficiently monitored
Taenaka Kogyo Co., Ltd.		 12 Apr 2024 Normal Justification: Observation shows that alarms are not effectively managed, risking unaddressed temperature excursions.
Excerpt: The alarm systems installed on such units throughout your facilities are configured to send email notifications to your Quality Control (QC) Manager, QC Test Manager, and Analytical Equipment Manager in the event one or more of the chambers experiences a temperature excursion.
View Details

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