Drugmaker Ipca Laboratories’ active pharmaceutical ingredients (API) manufacturing facility in Ratlam, Madhya Pradesh, has been issued Form 483 with 11 observations by the U.S. Food and Drug Administration (U.S. FDA).
“The Form 483 and the observations were issued on conclusion of an inspection of the facility by the U.S. FDA from June 5-13,” Ipca said in a stock exchange filing on June 14. The company said it will submit a comprehensive response on the observations to the U.S. FDA within the stipulated time and work closely with the agency to resolve these issues at the earliest.