Pfizer plant receives FDA warning letter for contamination of medicine
pharmafile | March 1, 2017 | News story | Manufacturing and Production | Copaxone, Mylan, Pfizer, Teva, generics
The FDA has issued a warning letter to Pfizer after inspectors discovered that the plant did not protect properly against the contamination of products. Pfizer had originally acquired the manufacturing facility in question, McPherson plant in Kansas, after the takeover of Hospira in 2015.
The issue was brought to light by Momenta Pharmaceutical which produces Glatopa, a Teva’s Copaxone generic. The medication is a 40mg version of Copaxone and had been predicted to take a considerable share of Copaxone market share. Luckily for Teva, the issues at the manufacturing plant have put a short-term hold on the release of the generic release.
The letter refers to medicine being found to be contaminated by cardboard – in particular three incidences of an injectable antibiotic, vancomycin, containing cardboard and was deemed to pose “a severe risk of harm to patients”. The most recent letter suggests that issues had not been fully addressed by the initial letters sent by the FDA, with the letter stating: “you closed the investigation without a comprehensive evaluation of the extent of the contamination and without taking further corrective actions”.
The warning does not indicate that any products that have recently been produced at the factory will have any safety issues. It is not clear how long it will take Pfizer to appease the FDA, with one out of five previous cases being resolved in months. However, it could potentially delay approval of the 40mg Glatopa generic until next year – allowing Mylan to catch up and potentially be the first to market with its own 40mg generic version.
Ben Hargreaves
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