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Sub System /
Asset Management
Asset Management
View Detailed Analysis

Analytics Overview

4
Form 483s Issued
0
483s converted to WL
4
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
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
12 Oct 2023
Dr. Reddy's Laboratories, Ltd, Biologics
Drugs
View Form 483
22 Oct 2021
Xinxiang Tuoxin Pharmaceutical Co., Ltd.
Drugs
View Form 483
15 Oct 2021
Abbott Nutrition
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Daniel B Arrecis
1
0
Elizabeth P Mayer
1
0
Joan Cantellops
1
0
Logan Williams
1
0
Madushini Dharmasena, PhD
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Asset Management encompasses maintaining equipment reliability. Observation describes instruments with functional damage, indicating lapses in equipment oversight.
Excerpt: Analytical balance ... appeared to have rust/corrosion, displayed defective side doors that did not open as expected.
View Details
The documentation and assessment of potential risks and abnormalities during GMP manufacturing are deficient
Dr. Reddy's Laboratories, Ltd, Biologics		 12 Oct 2023 Normal Justification: Asset management ensures filling components are adequately tracked to maintain product integrity and consistent operational performance.
Excerpt: The (b) (4) of (b) (4) used for the filling of (b) (4) (b) (4) drug product in is not documented or tracked.
View Details
The equipment used in the manufacturing of intermediates is not properly maintained for its intended use.
Xinxiang Tuoxin Pharmaceutical Co., Ltd.		 22 Oct 2021 Normal Justification: Asset management is crucial for ensuring equipment performance remains within specified requirements to prevent product contamination.
Excerpt: The (b) (4) equipment (ID: 07FS-001) located in Workshop used in the manufacturing of the intermediate was observed to be damaged.
View Details
You did not install a (b) (4) capable of (b) (4) when (b) (4) (b)(4) is used at a product filling machine.
Abbott Nutrition		 15 Oct 2021 Normal Justification: The observation centers around equipment installation, falling squarely under Asset Management, which deals with equipment adequacy and installation.
Excerpt: on Filler Lines (b) (4), , the finished product is (b) (4) .
View Details

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Go back

Asset 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

Asset Management

Overview

4
Form 483s Issued
0
483s converted to WL
4
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
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
12 Oct 2023
Dr. Reddy's Laboratories, Ltd, Biologics
Drugs
View Form 483
22 Oct 2021
Xinxiang Tuoxin Pharmaceutical Co., Ltd.
Drugs
View Form 483
15 Oct 2021
Abbott Nutrition
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Daniel B Arrecis
1
0
Elizabeth P Mayer
1
0
Joan Cantellops
1
0
Logan Williams
1
0
Madushini Dharmasena, PhD
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Asset Management encompasses maintaining equipment reliability. Observation describes instruments with functional damage, indicating lapses in equipment oversight.
Excerpt: Analytical balance ... appeared to have rust/corrosion, displayed defective side doors that did not open as expected.
View Details
The documentation and assessment of potential risks and abnormalities during GMP manufacturing are deficient
Dr. Reddy's Laboratories, Ltd, Biologics		 12 Oct 2023 Normal Justification: Asset management ensures filling components are adequately tracked to maintain product integrity and consistent operational performance.
Excerpt: The (b) (4) of (b) (4) used for the filling of (b) (4) (b) (4) drug product in is not documented or tracked.
View Details
The equipment used in the manufacturing of intermediates is not properly maintained for its intended use.
Xinxiang Tuoxin Pharmaceutical Co., Ltd.		 22 Oct 2021 Normal Justification: Asset management is crucial for ensuring equipment performance remains within specified requirements to prevent product contamination.
Excerpt: The (b) (4) equipment (ID: 07FS-001) located in Workshop used in the manufacturing of the intermediate was observed to be damaged.
View Details
You did not install a (b) (4) capable of (b) (4) when (b) (4) (b)(4) is used at a product filling machine.
Abbott Nutrition		 15 Oct 2021 Normal Justification: The observation centers around equipment installation, falling squarely under Asset Management, which deals with equipment adequacy and installation.
Excerpt: on Filler Lines (b) (4), , the finished product is (b) (4) .
View Details

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