Baxter Releases FDA Warning Letter for 2017 Inspection in India

By Chris Wack

Baxter International Inc. (BAX) said in a filing Tuesday that it has released a warning letter from the U.S. Food and Drug Administration regarding an inspection of the company's newly acquired facility in Ahmedabad, India in July 2017.

According to Baxter, the FDA began this inspection at the time of the closing of Baxter's buy of these facilities of Claris Injectables Limited. Baxter said it has responded to the letter, and has already implemented corrective actions to many of the issues raised in the warning letter.

Coming out of the 2017 inspection, Baxter didn't include any 2018 revenue for new Claris product launches in the U.S. in its 2018 financial guidance, and receipt of the letter won't cause any changes to its long-range financial guidance issued in May 2018.

Baxter is looking at potential new locations to help mitigate the risk of any delay to fully fix all of the FDA's problems with the India facility beyond the first half of 2020.

In the letter, the FDA has requested a meeting with the company, which Baxter expects to occur in 2018, with a reinspection of the Claris Injectables facility to follow. Baxter expects the new FDA inspection to occur by the end of the first half of 2019.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

July 17, 2018 12:35 ET (16:35 GMT)

Copyright (c) 2018 Dow Jones & Company, Inc.