New details about problems with the production of heparin and other drugs by APP Pharmaceuticals ($APPX) have been released by the Food and Drug Administration on its website.
The inspection report of the company's Jamaica, NY, plant claims that for 18 months the company didn't get around to doing an "Initial Impact Assessment," on the more than 400 consumer complaints about drugs made at the plant, including heparin. The complaints, received from January 2010 until inspectors arrived in June 2011, included everything from patient reactions to hair and insects found in vials. It said APP officials gave no reason for the laissez-faire attitude.
Inspectors also found that during media fill, some vials had particulates that a contract lab later identified as bacteria. And there was no sound basis for the sampling of products to guarantee that the samples were reflective of the products produced.
The release of the inspection report follows a warning letter sent by the FDA to APP last month. In it, the FDA questioned why the company had not fully investigated why some batches of heparin and heparin lock flush were out of spec. The FDA told APP to produce three years worth of out-of-specification results for the two products. The letter raked the company for also not resolving issues with an insect infestation in the plant.
In a press release, APP's German parent, Fresenius Kabi ($FRE), said it has made significant progress in addressing the problems and that it expects to complete enhancements without disrupting output. It said it has full confidence in the quality of its products.
The FDA has taken a harder look at heparin production after a 2008 episode when hundreds of patients had allergic reactions and more than 80 died from injections of contaminated heparin. The heparin, marketed by Baxter International ($BAX), was found to be contaminated by active ingredient from China. The FDA got beat up for having lax oversight of global production of the injectable anticoagulant.
APP was among 10 heparin producers to receive a letter last summer from a U.S. House of Representatives subcommittee asking how such a serious contamination was possible.
- read the FDA inspection report
- check out the warning letter
- here's the APP release