US FDA inspection completed at Caplin Steriles Injectable site at Gummidipoondi

We would like to inform you that the United States Food and Drug Administration (USFDA) had completed its GMP and PAI inspection of Caplin Steriles Limited’s (a subsidiary of Caplin Point Laboratories Limited) Sterile Injectable site at Gummidipoondi between May 22nd to 31st.

At the end of the inspection, there were four observations by US FDA. These observations are procedural in nature and the corrective and preventive actions for these observations will be presented to the US FDA within the stipulated period. The observations made were not repeat observations or related to data integrity.