Alkem Laboratories said the US health regulator has issued an establishment inspection report (EIR) for its manufacturing facility at Baddi in Himachal Pradesh. The Baddi facility was inspected by the United States Food and Drug Administration (US FDA) from February 17 to 21, 2020, Alkem Laboratories said in a filing to BSE.

The US FDA has now issued an EIR for the manufacturing facility, it added. On February 21, the company in a regulatory filing had said USFDA had issued a Form 483 with two observations at the end of the inspection of the facility. It had said it shall put together a detailed response with adequate corrective and preventive measures to address the US FDA observations.

Register as Visitor to CPhI China 2020!

-----------------------------------------------------------------------
Editor's Note:

En-CPhI.CN is a vertical B2B online trade platform serving the pharmaceutical industry,

for any copyright disputes involved in the articles,

please email: Julia.Zhang@imsinoexpo.com to motify or remove the content.