Caplin Point receives EIR from FDA with Zero 483 observations

Caplin Point Laboratories Ltd. announced that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the recent inspection conducted at Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi.

The unannounced USFDA inspection was conducted between August 5th and 9th, 2024 and was concluded with Zero 483 observations, reflecting the company’s commitment to maintaining the highest standards of quality and compliance.

The inspection, which is a routine part of the FDA’s regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a fast growing sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA.