Bayer Gets FDA Warning Over Manufacturing Practices at German Site
14 February 2018 - 3:01PM
Dow Jones News
By Marc Navarro Gonzalez
Bayer AG (BAYN.XE) has received a warning letter from the U.S.
Food and Drug Administration regarding drug manufacturing practices
at the company's supply center in Leverkusen, Germany.
The company said Wednesday that the letter was sent after a
routine inspection of the Leverkusen center in January, and that it
has been carrying out corrective measures since then.
"Bayer is fully committed to diligently addressing the FDA
observations and to continue the corresponding implementation of
necessary corrective actions," the company said in a statement.
The ongoing remediation and modernization works at the site are
likely to result in temporary supply limitations, Bayer said. It
said it will report the impact of these measures in its upcoming
guidance release on Feb. 28.
The company said that product release-and-distribution
operations continue at the Leverkusen site and that it has no
evidence that patient safety has been put at risk.
Write to Marc Navarro Gonzalez at
marc.navarrogonzalez@dowjones.com
(END) Dow Jones Newswires
February 14, 2018 09:46 ET (14:46 GMT)
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