Caplin Point Laboratories Limited has announced the completion of an unannounced inspection by the United States Food and Drug Administration at the manufacturing facility of its subsidiary, Caplin Steriles Limited. The inspection was conducted at the company's injectable and ophthalmic manufacturing plant located at Gummidipoondi, spanning from August 13, 2026, to August 21, 2026.

At the conclusion of the audit, the US regulatory authority issued a Form 483 containing 10 observations. The company clarified that all 10 observations are strictly procedural in nature. The company confirmed that none of the findings pertain to data integrity and there are no repeat observations from previous regulatory inspections.

Caplin Steriles Limited is currently working on addressing the observations comprehensively. The company intends to submit a detailed response and corrective action plan to the US FDA within the stipulated timeline.