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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

05 Oct 2023

XYZ Pharmaceutical Inc.

Drugs

View Form 483

15 Sep 2023

ABC Pharmaceuticals Inc.

Drugs

View Form 483

15 Sep 2023

XYZ Pharmaceuticals

Drugs

View Form 483

15 Sep 2023

XYZ Pharmaceuticals Inc.

Drugs

View Form 483

Top Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Jane Smith

John Doe

Alice Johnson

John Smith

Madushini N. Dharmasena, Ph.D.

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
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
Failure to investigate discrepancies XYZ Pharmaceuticals Inc.	15 Sep 2023	Normal	Justification: Packaging line setup is critical to ensuring processes don't deviate from specifications. Excerpt: A deviation occurred during the packaging process of Product X. View Details
Personnel training records were incomplete XYZ Pharmaceuticals	15 Sep 2023	Normal	Justification: Packaging Line Setup impacted due to inadequately trained personnel, risking operational errors. Excerpt: two employees working on the packaging line did not have documented evidence of training for the new SOP View Details
Failure to provide training for personnel in the production department ABC Pharmaceuticals Inc.	15 Sep 2023	Normal	Justification: Packaging Line Setup is affected because inexperienced operators risk errors in setting up new equipment. Excerpt: Operators responsible for the packaging line lacked documented evidence of training completion. 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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