APP Pharmaceuticals Cited for Major Quality Problems, Bugs
February 29th, 2012 // 2:16 pm @ jmpickett
File this under ‘a fine mess.’ The FDA has tagged APP Pharmaceuticals for so many systemic problems -insects; vials with missing labels; failed assays; contamination; floating particles and a failure to file reports or follow-up complaints – that the agency has instructed the executive team to “undertake a comprehensive and global assessment,†according to a warning letter issued last week.
The letter, in fact, reads like a how-to list – how to screw up, in this case. What is likely to generate wider notice, though, is a reference to problems a potential trend of failed assay results for different batches of both the active pharmaceutical ingredient and finished product. Now, the FDA wants APP to submit a three-year history of test results and subsequent internal investigations.
This is not the first time that APP has come under intense scrutiny for its role as a heparin marketer. APP was one of 10 drugmakers that was asked last year to provide information to Congress about the source of their ingredients in connection with adulterated heparin. Contaminated heparin from China was linked to 81 deaths in the US back in 2007 and 2008 (back story).
The FDA found still other problems. For instance, agency inspectors noticed during a visit to APP facilities in upstate New York that the drugmaker was manufacturing five unapproved drugs that generate about $20 million in annual sales, according to APP. You can read the letter and all the details about the myriad problems here.
APP, by the way, is owned by Fresenius Kabi, which is based in Germany. We asked an APP spokeswoman for a reply and will update you accordingly. [UPDATE: A spokeswoman send us a statement saying ongoing enhancements are under way and a response will be given to the FDA in the required 15-day timeframe.]
