Caplin Steriles Gets 10 USFDA Observations at Gummidipoondi Facility
Chennai: Caplin Point Laboratories Limited has informed the stock exchanges about the completion of an unannounced inspection conducted by the United States Food and Drug Administration (USFDA) at the injectable and ophthalmic manufacturing facility of its subsidiary, Caplin Steriles Limited, located at Gummidipoondi.
The inspection was conducted from August 13, 2026, to August 21, 2026, and concluded with the issuance of Form 483 containing 10 observations. According to the company, the observations are procedural in nature, do not pertain to data integrity, and none of them were repeat observations.
The inspection was carried out at Caplin Steriles' injectable and ophthalmic manufacturing facility at Gummidipoondi. The US FDA conducted the inspection without prior announcement, covering the period between August 13 and August 21, 2026. At the conclusion of the inspection, the company received Form 483 listing ten observations. The company specifically stated that these observations were procedural in nature and did not relate to data integrity. It also clarified that none of the observations were repeat observations.
Caplin Point Laboratories stated that it is addressing the observations comprehensively and will submit its response to the US FDA within the stipulated timeframe. The company requested the stock exchanges to take the information on record.
The company has formally notified the stock exchanges that the unannounced US FDA inspection at its subsidiary Caplin Steriles Limited's Gummidipoondi facility has been completed, with 10 procedural observations recorded through Form 483, with no data-integrity-related observation and no repeat observation, while the company is undertaking a comprehensive response within the stipulated timeframe.
