Last Updated on October 9, 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.
USFDA issues OAI status to Eugia Pharma of Aurobindo
USFDA inspection concluded at Solara Pharma without any observations
USFDA issued Form 483 with 6 observations to Lupin
USFDA inspection: With zero observation at Indoco Remedies
Drug recall: 51k bottles of generic Antibiotic Drug recalled
NPPA to recalculate ceiling price of Rheumatoid Arthritis Drug
New Schedule M: Impact on Cosmetic Manufacturing
DCGI approval granted for this new Antibiotic Drug Combination
Gujarat FDCA Cracks Down on Medical Stores: Licenses cancelled
Gujarat FDCA Cracks Down on Pharmaceutical Manufacturing Violations
CDSCO Panel Approves Benralizumab Solution For Injection In Auto-Injector
BIS Standards for Medical Device Testing in India
NABL Clarifies Test Method for Blood-Resistant PPE
Govt issues instructions on marketing codes of pharma companies
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
