The FDA has ordered a compounding pharmacy in Hollywood, FL, to stop repackaging Avastin after some of the syringes of the cancer drug were found to be contaminated with Streptococcus mitis/oralis and other microorganisms and tied to infections. The agency said that given the conditions of the facility and the practices of the employees, the drugs "may have been contaminated with filth."
In a hard-hitting letter hand-delivered during an outbreak investigation, the FDA said repackaging the Avastin, as well as human chorionic gonadotropin (HCG), was well beyond the purview of Infupharma. The FDA warning letter says investigators determined that Infupharma has a contract with another pharmacy to repack Avastin from sterile injectable single-use vials into sterile injectable 1 mL single-use syringes and to repack HCG multiuse vials into single-use syringes for further distribution. But the FDA said the repacking amounted to creating new drugs and that the company was not approved to do that.
Not only that, but the inspectors also found that the employees were untrained and inept and the conditions were unsanitary and that the company did not have separate work areas to "prevent contamination or mix-ups during the course of your aseptic processing."
The company also does not have established procedures and so had not fully investigated two complaints that patients had contracted eye infections after they received intraocular injections of Avastin repackaged by Infupharma, the FDA warning letter says.
In the spring, another Florida compounder, Franck's Pharmacy, went through a series of recalls for contaminated products also tied to eye infections and finally in May issued an "Urgent Alert" that it was recalling all of its products made since Nov. 21, 2011.
It has been a tough year for Roche ($RHHBY) when it comes to dealing with outside issues concerning Avastin. The company and the FDA have been investigating the distribution of counterfeit versions of the cancer drug earlier this year to physician practices throughout much of the U.S.
- here's the FDA warning letter
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