Caplin Point Laboratories announced the completion of an unannounced inspection by the United States Food and Drug Administration (US FDA) at its subsidiary, Caplin Steriles Limited’s, injectable and ophthalmic manufacturing facility. The inspection, which took place from August 13, 2026, to August 21, 2026, resulted in 10 observations. The company stated these are procedural and not related to data integrity, and are being addressed for response within the stipulated timeframe.
US FDA Inspection at Caplin Steriles Facility
Caplin Point Laboratories Limited has disclosed the conclusion of an unannounced inspection conducted by the United States Food and Drug Administration (US FDA) at the manufacturing facility of its subsidiary, Caplin Steriles Limited. This facility is located in Gummidipoondi and is dedicated to the production of injectable and ophthalmic products.
Inspection Details and Observations
The inspection commenced on August 13, 2026, and concluded on August 21, 2026. Following the inspection, the company received Form 483, detailing 10 (ten) observations. Caplin Point Laboratories has emphasized that these observations are procedural in nature and do not pertain to data integrity. Furthermore, none of the observations were identified as repeat issues.
Company’s Response and Next Steps
The company has affirmed that it is comprehensively addressing all the observations. Caplin Point Laboratories will submit its response to the US FDA within the mandated timeframe. This proactive approach aims to ensure continued compliance and operational standards at the subsidiary’s facility.
Source: BSE
