It's a Bug. It's a Bird. It's a Mouse. No, not bug nor bird nor even mouse, it's just compounder Ameridose.
Just when you thought the compounding scandal at the New England Compounding Center (NECC) couldn't get any worse, it does. It seems that another compounder sharing the NECC owner's also has been cited by the FDA with serious breeches in its quality systems.
Among other things found in its sterile processing and packaging areas -- besides the expected drugs -- were bugs, birds, rodents, mold, bacteria, and cracked and corroded walls. How did they miss bat wings and eye of newt?
Based on the meningitis outbreak caused by NECC preparations shipped to 24 States, Congress is now holding 2 sets of hearings to investigate why FDA does not have more oversight in this area -- or is not exercising more enformcement power that it may already have. I don't expect this issue to go away.
Unless of course, we find that it is a GMP bird trained to catch mice and bugs.
Posted by Bruce Lehr Nov 13th 2012.