Hikma Receives FDA Warning Letter for Portugal Manufacturing Facility

Hikma Pharmaceuticals PLC  reports that it received a Warning Letter from the US Food and Drug Administration on October 23, 2014 related to the agency’s inspection of the company’s manufacturing facility in Portugal in March 2014.

In the letter, the agency raised issues related to investigations and environmental monitoring at the facility. “Hikma takes this matter very seriously and will work with the FDA to fully resolve all outstanding issues,” said the company in a statement.

At this point, Hikma said it does not anticipate that the Warning Letter will impact the manufacturing or distribution of the products manufactured in its Portugal facility, and does not believe that it will impact its financial guidance for 2014.

Earlier this year, Hikma acquired Bedford Laboratories, the US generic injectables business of Ben Venue Laboratories, Inc., and later the Ben Venue manufacturing facility in Bedford, Ohio from Boehringer Ingelheim.  

The FDA Warning Letter may be found here.

Source: Hikma Pharmaceuticals

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