US FDA issued warning letter to Portugal Manufacturing Unit of Hikma Pharmaceuticals Inc.
US FDA inspected the Portugal Manufacturing Unit of Hikma Pharmaceuticals Inc in Mar 2014.The warning letter has been issued on 23rd Oct 2014.Issues related with investigations and environmental monitoring at the facility was observed by FDA due to which the warning letter has been issued. Although warning letter has been issued but there will be no impact in the manufacturing or distribution of products manufactured in the Portugal facility as per Hikma.
The company is taking the matter seriously and will be resolving the outstanding issues along with FDA.