rediff.com

USFDA Issues 7 Observations to Dr Reddy's Bollaram Unit

Share on:

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.
USFDA Issues 7 Observations to Dr Reddy's Bollaram Unit
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.
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.

TODAY'S MOST TRADED COMPANIES

  • Company Name
  • Price
  • Volume

More »

Moneywiz Live!