Fagron has received a warning letter from the FDA, the American medicines watchdog. The Belgian manufacturer of pharmaceutical preparations announced this on Monday. On the Brussels stock exchange, Fagron shares lost almost 12 percent.
This happened after a routine inspection at the Fagron branch in Wichita, Kansas. The letter obliges Fagron to improve the processes for investigating deviations and validating future production capacity.
Most of these improvements have already been addressed, according to Fagron. The company is working with the FDA to clarify any outstanding issues and reach a satisfactory resolution.
Fagron says it responded to the comments and organized a voluntary recall in August, “with a view to maximum caution”. It received no adverse event reports in this regard, and there was no material impact on its operations.
Investors were shocked by the finger tap and sent the share almost 12 percent lower at the opening.