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Primary Packaging

Primary Packaging

View Detailed Analysis

Analytics Overview

3

Form 483s Issued

0

483s converted to WL

3

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

03 Apr 2025

Thrive Health and Wellness, LLC, dba Thrive Health Solutions

Drugs

27 Mar 2024

Alkem Laboratories Limited

Drugs

14 Dec 2023

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Drugs

Top Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Nicole E Knowlton

1

0

Richard Ledwidge, Senior Biologist

1

0

Taichun Qin

1

0

Yiwei Li, Supervisory Chemist

1

0

Yvins Dezan

1

0

Observations

View all Observations

TITLE/ COMPANY	Issue Date	Status	Details
Use of a disinfectant in a manner insufficient to achieve adequate levels of disinfection. Thrive Health and Wellness, LLC, dba Thrive Health Solutions	03 Apr 2025	Normal	Justification: The cleanliness of surfaces directly impacts the primary packaging step, where unclean surfaces can contaminate products. Excerpt: The work surface is not disinfected prior to packaging vials into syringes. View Details
Control procedures are not established which Alkem Laboratories Limited	27 Mar 2024	Normal	Justification: Observation details specifically point towards failures in the primary packaging operations, including ignoring vital checks and process inaccuracies post a power outage, thus impacting product integrity and safety. Excerpt: The observation notes the lack of checks for HMI accuracy post power outage and mishandling of in-process products during primary packaging. View Details
Capping (b)(4) validation data to ensure container closure integrity is inadequate Suzhou Suncadia Biopharmaceuticals Co., Ltd.	14 Dec 2023	Normal	Justification: Capping of vials is a core activity in primary packaging. Container closure integrity is a critical function of the packaging process, and validation failure directly impacts packaging assurance. Excerpt: Studies... tested vials for container closure integrity using the commercial (b)(4) production capping parameters... justification for the sample size... was not provided. View Details

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Primary Packaging

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

Primary Packaging

Overview

3

Form 483s Issued

0

483s converted to WL

3

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

03 Apr 2025

Thrive Health and Wellness, LLC, dba Thrive Health Solutions

Drugs

27 Mar 2024

Alkem Laboratories Limited

Drugs

14 Dec 2023

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Drugs

Top FDA Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Nicole E Knowlton

1

0

Richard Ledwidge, Senior Biologist

1

0

Taichun Qin

1

0

Yiwei Li, Supervisory Chemist

1

0

Yvins Dezan

1

0

Key Observations

TITLE/ COMPANY	Issue Date	Status	Details
Use of a disinfectant in a manner insufficient to achieve adequate levels of disinfection. Thrive Health and Wellness, LLC, dba Thrive Health Solutions	03 Apr 2025	Normal	Justification: The cleanliness of surfaces directly impacts the primary packaging step, where unclean surfaces can contaminate products. Excerpt: The work surface is not disinfected prior to packaging vials into syringes. View Details
Control procedures are not established which Alkem Laboratories Limited	27 Mar 2024	Normal	Justification: Observation details specifically point towards failures in the primary packaging operations, including ignoring vital checks and process inaccuracies post a power outage, thus impacting product integrity and safety. Excerpt: The observation notes the lack of checks for HMI accuracy post power outage and mishandling of in-process products during primary packaging. View Details
Capping (b)(4) validation data to ensure container closure integrity is inadequate Suzhou Suncadia Biopharmaceuticals Co., Ltd.	14 Dec 2023	Normal	Justification: Capping of vials is a core activity in primary packaging. Container closure integrity is a critical function of the packaging process, and validation failure directly impacts packaging assurance. Excerpt: Studies... tested vials for container closure integrity using the commercial (b)(4) production capping parameters... justification for the sample size... was not provided. View Details

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