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Packaging Line Setup

View Detailed Analysis

Analytics Overview

Form 483s Issued

483s converted to WL

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

12 Sep 2025

Dr. Reddy's Laboratories, LTD, Biologics

Drugs

View Form 483

15 Oct 2023

ABC Pharmaceuticals Inc.

Drugs

View Form 483

10 Oct 2023

Sunshine Foods Inc.

Drugs

View Form 483

05 Oct 2023

Example Pharma Corp.

Drugs

View Form 483

05 Oct 2023

XYZ Pharmaceutical Inc.

Drugs

View Form 483

Top Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Jane Smith

John Doe

John Smith

Jane Doe

Dr. John Smith

Observations

View all Observations

TITLE/ COMPANY	Issue Date	Status	Details
Written documents are inadequate to ensure proper documentation and analysis of critical manufacturing operations Dr. Reddy's Laboratories, LTD, Biologics	12 Sep 2025	Normal	Justification: Observation indicates a deviation from required operations during the filling line setup, impacting packaging integrity. Excerpt: Step (b) (4) (...) not performed during the (0)(4) filling line setup. View Details
Your firm failed to thoroughly review any unexplained discrepancy ABC Pharmaceuticals Inc.	15 Oct 2023	Normal	Justification: Line setup issues noted, directly linking to repeated jamming incidents affecting process continuity. Excerpt: Deviation occurred where the packaging line jammed repeatedly, resulting in interruptions to the sealing process. View Details
Failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed Sunshine Foods Inc.	10 Oct 2023	Normal	Justification: The mix-up related to packaging material setup highlights failures in correct line setup processes. Excerpt: A mix-up in packaging material for Batch #456-BX. The incorrect carton was used during the packaging of lot A123, resulting in potential mislabeling. View Details
Inadequate control of packaging material to prevent mix-ups XYZ Pharmaceuticals	05 Oct 2023	Normal	Justification: Proper setup of packaging lines is essential to prevent errors like label mixing. Excerpt: There was no documented control in place to ensure the proper labeling. View Details
Training records indicate that employees involved in the packaging process XYZ Pharmaceutical Inc.	05 Oct 2023	Normal	Justification: Packaging Line Setup is linked as accurate training ensures correct setup and functioning of packaging processes. Excerpt: Employees involved in the packaging process for product 456 were not consistently trained. View Details

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Packaging Line Setup

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

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Overview

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Recent Form 483s

Top FDA Investigators

Key Observations

FAQ

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