Pfizer Inc. ($PFE) reported that the company has received a warning letter from the FDA regarding its operations at a plant in McPherson, Kansas. The plant is used for manufacturing sterile injectable drugs. The letter stated that the company’s process at the plant was ‘out of control.’
The warning letter further stated that several products were contaminated with multiple foreign particulates and that the injectable antibiotic vancomycin had been compromised by cardboard pieces. The regulator has accused the company for failing to take any corrective actions.
However, Pfizer stated that it has been "diligently implementing commitments made to the FDA.” The company uses the plant for producing treatments for other companies as well.
Pfizer stock has gained over 12 percent in the past 12 months while its Year to Date gain stands at 5 percent. The company also announced the results for an oral strategy for treating rheumatoid arthritis in patients showing moderate to severe symptoms with Xeljanz, a JAK inhibitor.
The results proved that Xeljianz was in no way inferior to Humira, an AbbVie Inc drug. However, testing of the JAK inhibitor without the combination of any other drug showed that the drug did not work as well as it did when used in combination. The study had 1,152 patients enrolled.