The agency’s warning followed an inspection of the facility that took place in January and February, though Gilead since said they responded to the FDA’s observations in March, and are “working diligently” to resolve any further problems.
The letter outlined inadequacies at the manufacturing plant as well as voicing concern over how effectively duties were being carried out.
According to Gilead, if outstanding issues are not corrected to the FDA’s satisfaction, the agency may withhold permission to export the company’s antifungal drug, AmBisome, to certain countries outside the US and Europe.”
Adding to the biopharmaceutical firm’s worries, it is also within the FDA’s rights to withhold approval of pending drug applications, which have been developed at the San Dimas plant. This potentially could have serious consequences on Gilead’s ability to supply its aseptically packaged products outside of the US, some of which include AmBisome, Cayston for cystic fibrosis, and Macugen; an eye drug.