U.S. FDA issues two observations to Dr. Reddy's API plant in Telangana
The U.S. FDA conducted a Good Manufacturing Practices (GMP) inspection of the API manufacturing facility (CTO-5) in Miryalaguda from May 19-24. 'We have been issued a Form 483 with 2 observations, which we will address within the stipulated timeline,' the company said in a filing on Saturday.
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