US Food and Drug Administration (USFDA) has completed inspection at Caplin Steriles’ Injectable site at Gummidipoondi between June 6 and June 14, 2019. Caplin Steriles is a Wholly Owned Subsidiary of Caplin Point Laboratories.
At the end of this scheduled GMP inspection, there were only two observations. The company believes these to be of procedural in nature and the corrective and preventive actions for these observations will be presented to the US FDA shortly. 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.
