Baxter Releases FDA Warning Letter for 2017 Inspection in India
July 17 2018 - 12:50PM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
July 17, 2018 12:35 ET (16:35 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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