By: IPP Bureau
Last updated : September 05, 2023 10:28 am
The inspection classification was determined by the agency as Voluntary Action Indicated
Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories Ltd, announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable and ophthalmic manufacturing unit located near Chennai.
The unit underwent an inspection from US FDA during May 22nd ~ May 31st and the inspection classification was determined by the agency as Voluntary Action Indicated (VAI).
Commenting on the achievement, C.C. Paarthipan, Chairman said: "This is the fourth US FDA audit at this site and we're pleased to receive the EIR with a satisfactory outcome. Our commitment to maintaining the highest levels of compliance at all our units remains steadfast. The receipt of EIR will help in receiving continued ANDA approvals for this unit, which is an important growth engine for us."