USFDA Issues 7 Observations to Dr Reddy's Bollaram Unit
0 Comments । By Black Cat News । 20 November, 2024
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.
SARDAR DILIP SINGH's Report
BlackCatNews, Hyderabad
