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Sub System /
Reagents and Standards
Reagents and Standards
View Detailed Analysis

Analytics Overview

1
Form 483s Issued
0
483s converted to WL
2
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

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Joan Cantellops
2
0
Logan Williams
2
0
Megan Ziegler
2
0
Santos Camara
2
0
TITLE/ COMPANY Issue Date Status Details
Laboratory records do not include complete records of any testing and standardization of laboratory standard solutions.
Exela Pharma Sciences LLC
15 Nov 2024 Normal Justification: The observation directly concerns the stability and suitability of laboratory resolution solutions, which fall under the management of reagents and standards.
Excerpt: There is no scientific rationale to support that a resolution solution is stable indefinitely, such as continuous monitoring nor assessment of the chromatographic behavior of this resolution solution since the initial use in 2021.
View 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: Proper handling of laboratory reagents and standards ensures quality testing. The observation outlines inadequate segregation and traceability, posing contamination risks.
Excerpt: Laboratory reference standards ... were not segregated from reagents and test solutions to prevent possible mix-ups and contamination.
View Details

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Reagents and Standards

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

Reagents and Standards

Overview

1
Form 483s Issued
0
483s converted to WL
2
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
15 Nov 2024
Exela Pharma Sciences LLC
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Joan Cantellops
2
0
Logan Williams
2
0
Megan Ziegler
2
0
Santos Camara
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Laboratory records do not include complete records of any testing and standardization of laboratory standard solutions.
Exela Pharma Sciences LLC
15 Nov 2024 Normal Justification: The observation directly concerns the stability and suitability of laboratory resolution solutions, which fall under the management of reagents and standards.
Excerpt: There is no scientific rationale to support that a resolution solution is stable indefinitely, such as continuous monitoring nor assessment of the chromatographic behavior of this resolution solution since the initial use in 2021.
View 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: Proper handling of laboratory reagents and standards ensures quality testing. The observation outlines inadequate segregation and traceability, posing contamination risks.
Excerpt: Laboratory reference standards ... were not segregated from reagents and test solutions to prevent possible mix-ups and contamination.
View Details

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