FDA finds 'filth' at compounder repackaging Avastin

September 6, 2012 | By Eric Palmer

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."

Read rest of article at: FDA finds 'filth' at compounder repackaging Avastin - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-finds-filth-compounder-repackaging-avastin/2012-09-06#ixzz25iFBBm4m