Caplin Steriles Receives US FDA Form 483 with 10 Observations

Caplin Point Laboratories Limited disclosed that its subsidiary, Caplin Steriles Limited, underwent an unannounced inspection by the United States Food and Drug Administration (US FDA). The inspection was conducted at Caplin Steriles' injectable and ophthalmic manufacturing facility located in Gummidipoondi.

The inspection period spanned from August 13, 2026, to August 21, 2026. At the conclusion of the inspection, the company received Form 483 containing 10 observations. According to the disclosure, all observations are procedural in nature and do not pertain to data integrity. Additionally, none of the observations were repeat observations from previous inspections.

The company stated that it is addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe. The disclosure was signed by Venkatram G, General Counsel & Company Secretary (Membership No A23989), on behalf of Caplin Point Laboratories Limited.