The warning letter is an escalation of the official action indicated (OAI) classification of the inspection conducted by the US regulatory agency from April 15 to April 23, 2024.
The warning letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. The company has to submit its response to the letter in 15 days.
Zydus said the warning Letter does not contain any data integrity related violations.
“The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility,” Zydus said in a statement to stock exchanges.
The warning letter doesn’t impact existing supplies from the manufacturing site but restricts new launches, which is critical for business growth in US market.Shares of Zydus dropped 0.35% to end at Rs 1128.30 on BSE on Friday, while the benchmark Sensex gained 0.28% to close at 82,365.77 points.
