The FDA last month issued a warning letter to Pfizer's sterile injectables plant in Kansas, problems at which derailed the expected approval of the long-lasting generic version of Teva’s Copaxone from Momenta and Sandoz. Now the FDA has posted details of the inspection that led to the letter.
While problems at the plant have already been made public in the warning letter, the highly redacted, 14-observation Form 483, offers up some more context of why the agency finally issued a warning letter to a plant that has long had problems meeting some basic FDA expectations.
A number of observations, for example, tracked back to the fact that the plant had used labels on vials of Diltiazem ADD angina medication there were best used on glass vials, not the plastic ones the plant put them on. The result was repeated customer complaints for peeling and double labels.
“Despite performing an investigation with a root cause implicating an entire product line and finding widespread impact across the line,” the agency said the plant did not investigate beyond individual lots to the whole line.
When investigations were done, they did not always recognize trends that could affect other runs of products. Field alerts were not made, the plant didn’t properly notify the agency of a major design change in the drug delivery system for a product and there were problems following proper procedures to prevent microbiological contamination of its injected drugs.
Pfizer has said it is working hard to resolve the FDA's concerns but the agency said in the warning letter Pfizer should have recognized long ago there were issues that needed addressing because the agency had cited five other Hospira plants for similar problems in four warning letters issued in 2010, 2013, 2014 and 2015.
“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the warning letter said.
While Pfizer is dealing with an unhappy FDA, Sandoz and Momenta was left to deal with surprised shareholders. The companies had expected approval this quarter of the 40-mg dose of Glatopa, their generic of Teva’s Copaxone. The partners already have a 20-mg version of the drug on the market but the long-lasting version is considered much more valuable. Teva sold $3.6 billion worth of Copaxone last year. Now it is uncertain whether they will be able to get an approval yet this year.