24th Oct 2014 06:31
LONDON (Alliance News) - Hikma Pharmaceuticals PLC Friday said it had received a warning letter from the US Food and Drug Administration related to an inspection of its manufacturing facility in Portugal conducted in March, although it stressed it does not believe this will impact its financial guidance for the full year.
In the letter, the FDA raised issues related to investigations and environmental monitoring at the the facility, Hikma said.
Hikma said it "takes this matter very seriously and will work with the FDA to fully resolve all outstanding issues." At this point, it does not expect this letter to impact the manufacturing or distribution of products manufactured at the facility.
Earlier this year the FDA cleared its compliance warning over Hikma's Eatontown facility in New Jersey, after issuing a warning letter about the facility in February 2012, which led to the company halting production at Eatontown.
Hikma said it "remains committed to the highest standards of quality and compliance across its 27 manufacturing facilities in 11 countries."
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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