Caplin Point Laboratories’ sterile injectable site completes FDA inspection

Caplin Point Laboratories, an Indian pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has concluded its Good Manufacturing Practices (GMP) and Pre-Approval Inspection (PAI) of Caplin Steriles Limited’s sterile injectable site located in Gummidipoondi in the Thiruvallur district of Tamil Nadu.

The inspection took place from May 22nd to 31st, and the outcome was positive overall.

Following the inspection, the US FDA issued four observations, which are primarily procedural in nature. It is important to note that these observations do not pertain to data integrity and are not repetitive in nature. Caplin Point Laboratories is committed to addressing these observations promptly and has initiated corrective and preventive actions to ensure compliance with the US FDA’s requirements.

Caplin Point Laboratories will submit the necessary documentation outlining the corrective and preventive measures within the stipulated timeframe provided by the US FDA. The company aims to swiftly resolve the observations and demonstrate its commitment to maintaining the highest quality standards in its manufacturing processes.