Hikma receives warning letter from US FDA
Over environmental monitoring issues at its plant in Portugal
Jordanian pharmaceutical manufacturer Hikma has received a warning letter from the US Food and Drug Administration raising issues related to investigations and environmental monitoring at its plant in Portugal.
The plant, which produces powder, liquid and lyophilised injectable drugs for the US and EMEA markets, was inspected by the US regulator in March.
During the inspection at the plant in Terrugem, Portugal, the FDA said it identified 'significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals'.
The FDA said Hikma had failed to conduct thorough investigations of its environmental monitoring (EM) excursions (i.e. exceeds action levels) found in Class 100 areas. All investigation reports identified possible root causes of the EM excursions as mishandling and/or poor aseptic technique during sampling. According to the inspectors, the company was unable to determine an actual root cause, yet 'disregarded the EM excursions without justification'.
The company also failed to evaluate the potential impact of these excursions on the quality of the product manufactured and failed to provide adequate challenge test set vials to qualify its operators and Quality Assurance (QA) staff to perform visual inspection of the drug product.
Hikma said it would work with the FDA to resolve all of the issues, adding that it did not anticipate any impact on manufacturing or distribution of products from the plant.
The company also said the warning is not expected to have an impact on its financial guidance for the year.