U.S. FDA issues observations to Dr. Reddy’s unit in Srikakulam
The United States Food and Drug Administration (U.S. FDA) has issued a Form 483 with three observations to Dr. Reddy’s Laboratories after inspecting a formulations manufacturing facility of the drugmaker in Andhra Pradesh. “The U.S. FDA today completed a product-specific pre-approval inspection (PAI) at our formulations manufacturing facility (FTO SEZ PU1) in Srikakulam, Andhra Pradesh. The inspection was conducted from August 19-23. We have been issued a Form 483 with three observations, which we will address within the stipulated timeline,” Dr. Reddy’s said in a filing on Friday.
Disclaimer: The copyright of this article belongs to the original
author. Reposting this article is solely for the purpose of information
dissemination and does not constitute any investment advice. If there is
any infringement, please contact us immediately. We will make
corrections or deletions as necessary. Thank you.