United States Food and Drug Administration (USFDA) has completed its GMP and PAI inspection at Caplin Point Laboratories’ subsidiary -- Caplin Steriles’ Sterile Injectable site at Gummidipoondi between May 22, 2023 to May 31, 2023.
At the end of the inspection, there were four observations by USFDA. 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.
Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.
