An API, or active pharmaceutical ingredient, is the key component of a drug that produces the desired therapeutic effect.

What are the potential consequences of a Form 483?

A Form 483 can lead to various consequences, including warning letters, import alerts etc.

How does a Form 483 impact a company's stock price?

The issuance of a Form 483 can negatively impact a company's stock price as it raises concerns about regulatory compliance and potential supply chain disruptions.

USFDA issued Form 483 with 7 observations to Dr Reddy’s

A Form 483 is issued by the USFDA to a company's management at the end of an inspection.

The Health Master

November 20, 2024

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Last Updated on December 21, 2024 by The Health Master

Form 483

Dr Reddy’s Laboratories Ltd announced on Tuesday that its active pharmaceutical ingredient (API) manufacturing facility in Bollaram, Hyderabad, received a Form 483 from the US Food and Drug Administration (USFDA).

This regulatory action indicates that the USFDA inspectors identified seven observations during their recent inspection, which was conducted from November 13 to 19, 2024.

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What is a Form 483?

A Form 483 is issued by the USFDA to a company’s management at the end of an inspection.

It highlights any conditions or practices that may violate the Food, Drug, and Cosmetic Act (FD&C Act) and related regulations.

These observations can range from minor documentation issues to more serious quality control problems.

Impact on Dr Reddy’s

While the issuance of a Form 483 is not uncommon in the pharmaceutical industry, it can have potential implications for a company’s operations.

Dr Reddy’s will need to address the seven observations raised by the USFDA within a specific timeframe.

Failure to rectify these issues could lead to further regulatory actions, including warning letters or import alerts.

Dr Reddy’s Response

In response to the Form 483, Dr Reddy’s has committed to addressing the observations promptly and effectively.

The company will likely implement corrective and preventive actions (CAPAs) to rectify the identified deficiencies.

The timely and successful completion of these CAPAs is crucial to maintaining compliance with USFDA regulations and ensuring the continued supply of Dr Reddy’s products to the US market.

Key Takeaways:

Dr Reddy’s Bollaram facility received a Form 483 with seven observations from the USFDA.
The observations were identified during an inspection conducted from November 13 to 19, 2024.
Dr Reddy’s is committed to addressing the observations and ensuring regulatory compliance.
The timely resolution of the issues is crucial for maintaining the supply of Dr Reddy’s products to the US market.

Also read following FAQs

What is an API?

An API, or active pharmaceutical ingredient, is the key component of a drug that produces the desired therapeutic effect.
What are the potential consequences of a Form 483?

A Form 483 can lead to various consequences, including warning letters, import alerts etc.
How does a Form 483 impact a company’s stock price?

The issuance of a Form 483 can negatively impact a company’s stock price as it raises concerns about regulatory compliance and potential supply chain disruptions.

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.