USFDA issues Form 483 with 4 observations to Dr. Reddy’s

A Form 483 is an official document issued by the USFDA to a pharmaceutical company following an inspection.

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USFDA Inspection audit Form 483
USFDA Form 483

Last Updated on June 15, 2024 by The Health Master

Form 483

Dr. Reddy’s Laboratories (DR Reddy) received a Form 483 from the US Food and Drug Administration (USFDA) following a GMP inspection at its Srikakulam API facility.

Main Points:

  • Dr. Reddy’s Laboratories (DR Reddy) received a Form 483 from the US Food and Drug Administration (USFDA) following a GMP inspection at its Srikakulam API facility (CTO-6).
  • The Form 483 outlines four observations identified by the USFDA during the inspection.
  • DR Reddy committed to addressing these observations within the stipulated timeframe.
  • This comes after a previous Form 483 issued by the USFDA in May 2024 for its Visakhapatnam formulations facilities.

DR Reddy Receives USFDA Form 483 for Srikakulam API Unit

On June 7, 2024, Dr. Reddy’s Laboratories, a leading pharmaceutical company in India, announced that the USFDA had issued a Form 483 following a Good Manufacturing Practices (GMP) inspection conducted at its Active Pharmaceutical Ingredient (API) manufacturing facility located in Srikakulam, Andhra Pradesh (CTO-6).

The inspection took place from May 30th to June 7th, 2024.

What is a Form 483?

A Form 483 is an official document issued by the USFDA to a pharmaceutical company following an inspection.

This document outlines observations made by the USFDA that may indicate potential violations of Good Manufacturing Practices (GMP) regulations.

These observations do not necessarily imply a final determination of non-compliance, but they do require the company to address them within a specific timeframe.

DR Reddy’s Response to the Form 483

Dr. Reddy’s has acknowledged receipt of the Form 483 and has expressed its commitment to addressing the identified observations within the stipulated timeframe.

The company has not disclosed the specific nature of the observations, but it is likely that they relate to deviations from established GMP procedures.

Previous USFDA Inspection at Dr. Reddy’s Facilities

It’s important to note that this is not the first time Dr. Reddy’s has received a Form 483 from the USFDA in recent months.

In May 2024, the USFDA issued a Form 483 with two observations following an inspection of Dr. Reddy’s formulations manufacturing facilities (FTO-7 & FTO-9) located in Duvvada, Visakhapatnam, Andhra Pradesh.

Impact on Dr. Reddy’s

The impact of the Form 483 on Dr. Reddy’s is yet to be determined.

The company’s stock price did experience a slight decline in May 2024 following the previous USFDA inspection.

However, the long-term impact will depend on the severity of the observations and Dr. Reddy’s ability to address them effectively.

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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