21-Aug-2026 19:14:26

CAPLIN POINT LABORATORIES : COMPLETION OF US FDA INSPECTION

• Unannounced inspection of Caplin Steriles' injectable and ophthalmic manufacturing facility in Gummidipoondi conducted between August 13, 2026, and August 21, 2026. • Company received Form 483 with 10 observations at the end of the inspection. • Observations are procedural and do not pertain to data integrity; none were repeat observations. • The company is addressing the observations and will respond to the US FDA within the stipulated timeframe.

Caplin Point Laboratories Limited

← Back to feed