Chennai, January 06, 2025: Caplin Point Laboratories Ltd. (“Caplin Point” or the “Company”) (BSE: 524742 | NSE: CAPLIPOINT), announced today that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the recent inspection conducted at Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The unannounced USFDA inspection was conducted between August 5th and 9th, 2024 and was concluded with Zero 483 observations, reflecting the company’s commitment to maintaining the highest standards of quality and compliance.
This press release follows the intimation made to the Stock Exchanges on August 9th, 2024 immediately upon completion of the inspection about its outcome. The inspection, which is a routine part of the FDA’s regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.