USFDA issues Form 483 with 5 observations to Torrent Pharma

A Form 483 is a critical document issued by the USFDA to a firm's management at the conclusion of an inspection.

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USFDA Inspection audit Form 483
USFDA Form 483

Last Updated on June 25, 2024 by The Health Master

Form 483

Torrent Pharmaceuticals Ltd., a leading Indian pharmaceutical company, recently announced that its manufacturing facility in Indrad, Gujarat, received a Form 483 from the US Food and Drug Administration (USFDA) following a pre-approval inspection (PAI) and Good Manufacturing Practices (GMP) inspection conducted between June 3rd and June 12th, 2024.

Form 483: Potential Violations Identified

A Form 483 is a critical document issued by the USFDA to a firm’s management at the conclusion of an inspection.

It signifies that the inspecting officer has observed conditions that might potentially violate the Food Drug and Cosmetic (FD&C) Act and related regulations.

In this instance, the USFDA identified five areas for improvement at Torrent Pharma’s Gujarat facility.

It’s important to note that the company clarified there were no observations related to data integrity, a significant concern during such inspections.

Torrent Pharma’s Response and Next Steps

Torrent Pharma has assured stakeholders that they will respond promptly to the USFDA within the designated timeframe.

The company emphasizes its commitment to working closely with the regulatory agency to address the observations and ensure complete compliance at the earliest opportunity.

A Crucial Focus

The US market is a vital growth driver for Indian pharmaceutical companies.

Maintaining compliance with USFDA regulations is paramount for uninterrupted market access and continued business success.

Torrent Pharma’s swift response and collaborative approach demonstrate their commitment to upholding the highest quality standards and ensuring the continued supply of safe and effective medications to the US market.

Addressing USFDA Observations

While the specific details of the USFDA observations haven’t been disclosed, Torrent Pharma’s proactive response is a positive sign.

By working diligently to address these concerns, the company can solidify its position as a reliable supplier of pharmaceutical products in the crucial US market.

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

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