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Reagents and Standards

Reagents and Standards

View Detailed Analysis

Analytics Overview

1

Form 483s Issued

0

483s converted to WL

2

Total Observation

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

Observations

View all 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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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

ON THIS PAGE

Recent Form 483s

Top FDA Investigators

Key Observations

Back to the Top

Reagents and Standards

Overview

1

Form 483s Issued

0

483s converted to WL

2

Total Observation

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

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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