USFDA Issues 7 Observations to Dr Reddy's Bollaram Unit
By Rediff Money Desk, New Delhi Nov 19, 2024 19:08
Dr Reddy's Laboratories received seven observations from the USFDA following an inspection of its Bollaram facility. The company will address the observations within the stipulated timeline.
New Delhi, Nov 19 (PTI) Dr Reddy's Laboratories Ltd on Tuesday said the US health regulator has issued a Form 483 with seven observations to its active pharmaceutical ingredient manufacturing facility in Bollaram, Hyderabad.
"The US Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad," Dr Reddy's Laboratories Ltd (DRL) said in a regulatory filing.
The inspection was conducted from November 13-19, 2024, it added.
"We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," the company said.
As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"The US Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad," Dr Reddy's Laboratories Ltd (DRL) said in a regulatory filing.
The inspection was conducted from November 13-19, 2024, it added.
"We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," the company said.
As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Source: PTI
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
You May Like To Read
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- ARC Finance
- 1.34 (+ 4.69)
- 117414945
- Vodafone Idea L
- 7.77 (+ 4.02)
- 78706608
- Srestha Finvest
- 0.86 (+ 2.38)
- 39218412
- Franklin Industries
- 2.46 ( -4.65)
- 16530594
- G G Engineering
- 1.50 ( -0.66)
- 12389377
MORE NEWS
Maharashtra CM Launches Technical Textile...
Maharashtra CM Devendra Fadnavis announces the establishment of Maharashtra Technical...
SBI Life Invests in Bima Sugam India Federation
SBI Life has acquired a 10% stake in Bima Sugam India Federation, an insurance...
Sebi Allows Non-Convertible Securities...
Sebi has updated insider trading norms, permitting subscription to non-convertible...