2 weeks ago
Dr Reddy's receives four USFDA observations for Hyderabad plant
Medicine companies follow strict rules to make sure their medicines are safe.
A group called the FDA visits factories to check that the rules are being followed.
In August, the FDA visited a Dr Reddy's medicine-making factory in Hyderabad, India.
The visit lasted from August 6 to August 14.
At the end of the visit, the FDA gave the company a paper called a Form 483.
That paper listed four things the inspectors had questions about.
Getting a Form 483 is not a punishment — it is a chance for the company to explain or fix the issues.
Dr Reddy's said it would fix the issues within the time given.
After the news, the company's shares on the stock market went down only a tiny bit.
Dr Reddy's Laboratories received four observations from the US Food and Drug Administration following an inspection of its formulations manufacturing facility in Bachupally, Hyderabad.
The FDA conducted a Good Manufacturing Practices inspection of the FTO-3 facility from August 6 to August 14.
The inspection concluded with the FDA issuing a Form 483 containing four observations.
Dr Reddy's did not disclose the nature of the observations or any potential impact on facility operations, and said it would address them within the stipulated timeline.
Dr Reddy's shares closed Friday at ₹1,200 on the NSE, down 0.5% from the previous session.
- Who
- Dr Reddy's Laboratories, an Indian pharmaceutical company, and the US Food and Drug Administration (USFDA).
- What
- The USFDA issued a Form 483 with four observations to Dr Reddy's following a Good Manufacturing Practices inspection of its formulations manufacturing facility.
- Where
- The FTO-3 formulations manufacturing facility in Bachupally, Hyderabad.
- When
- The inspection was conducted from August 6 to August 14.
- Why
- The FDA issues a Form 483 when investigators observe conditions that, in their judgment, may constitute violations of US regulatory requirements.
Key facts
- Company
- Dr Reddy's Laboratories
- Regulator
- US Food and Drug Administration (USFDA)
- Facility
- FTO-3 formulations manufacturing facility, Bachupally
- Location
- Hyderabad, India
- Inspection period
- August 6–14
- Outcome
- Form 483 with four observations
- Share price close (NSE)
- ₹1,200, down 0.5%
- Disclosure
- Regulation 30 of SEBI listing regulations
Sources
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