USFDA completes PADE inspection at Marksans with 2 observations

Following the comprehensive inspection, the USFDA has highlighted two observations.

163
USFDA Inspection
USFDA Inspection

Last Updated on October 6, 2024 by The Health Master

PADE inspection at Marksans

A leading pharmaceutical company, Marksans, has made a significant announcement regarding its recent post-marketing adverse drug experience (PADE) inspection conducted by the United States Food and Drug Administration (USFDA).

The inspection, which took place at the company’s Goa, Verna manufacturing facilities, concluded with noteworthy observations.

This development underscores Marksans‘ ongoing commitment to ensuring the safety and quality of its marketed products.

Thorough PADE Inspection

From July 31, 2023, to August 4, 2023, the USFDA conducted a meticulous post-marketing adverse drug experience (PADE) inspection at Marksans‘ Goa, Verna manufacturing facility.

This inspection was geared towards evaluating the company’s practices and procedures related to the reporting of adverse events associated with its marketed products.

The goal was to ensure that any potential issues or concerns were identified and addressed promptly, thus upholding the highest standards of safety and quality.

Observations Arising from Inspection

Following the comprehensive inspection, the USFDA has highlighted two observations.

These observations serve as crucial insights that will guide Marksans in further enhancing its operational protocols and compliance measures.

It’s important to note that observations made by regulatory authorities are valuable opportunities for companies to fine-tune their processes and systems, ultimately resulting in better product safety and patient outcomes.

Commitment to Corrective and Preventive Actions (CAPA)

Marksans is taking a proactive approach in response to the observations made during the PADE inspection.

The company is dedicated to swiftly addressing these observations by developing a comprehensive Corrective and Preventive Action (CAPA) plan.

This plan will outline specific steps and strategies to rectify the identified issues, prevent their recurrence, and bolster the overall quality of its operations.

Also read: NSQ Drug: Route cause analysis and CAPA

Submission to USFDA

The CAPA plan will be meticulously prepared within the stipulated time frame and subsequently submitted to the USFDA.

This submission demonstrates Marksans‘ transparent commitment to collaboration with regulatory authorities and its resolute dedication to continuous improvement.

By submitting a robust CAPA plan, Marksans aims to showcase its accountability and proactive stance in upholding the highest industry standards.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.

NSQ Drug: Route cause analysis and CAPA

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news