Federal investigators found visible mold inside the Framingham pharmacy at the center of the national fungal meningitis outbreak, including 83 vials from one lot of the tainted steroid used to treat back pain that contained “greenish black foreign matter.’’
An additional 17 vials in that bin of 321 vials of methylprednisolone acetate had white fibers floating in them during the inspection, according to a report released Friday by the US Food and Drug Administration that depicts a plant where safety practices were lax and contaminants widespread.
Comments
We certainly hope that all those Liberetards who keep whining about too much gummint regerlation have been following this story.
It is NOT the lack of regulation that resulted in the DPH problems. It is the lack of knowledge, and skills of the Regulators. The lack of state administration skills at the Jamaica Plan & the scenario at the Framingham pharaceutical company are very similar. Inadequate skills of Administrators; sloppy management, no checks & balances, . . . hopefully a thorough Federal Investigation will tell us more.
Excellent article, Liz -- very informative and well-written. >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Sounds like "unannounced" inspections are already improving things and they haven't even been started! >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Per the article, "The FDA report also indicated that the firm did not do proper sterility testing on the tainted batch of steroids, sending out just one vial from the entire lot for testing — a vial that passed the test." >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Sure, statistically testing more samples from a production run increases the liklihood that random contanimation will be detected. But if the contamination is not random then the procedure will be less effective. >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> For instance, 1 vial is contaminated by human act, or the contaminant is introduced into the environment at the end of the production run. 20 vials out of 100 are tested, but the contaminated vial is not one of them. I'm guessing that the liklihood of this kind of time dependent contamination is low, and, therefore, testing of a percentage of samples should give a high confidence level. Just wanted to cover it to be complete. >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> The other issue is less academic. How do you know the test was accurate? Especially if the testing is done one at a time by human beings. People make mistakes, and they make them ALL THE TIME. You would hear more about them in the media if it were not in the best interests of the mistake-maker, and their employer, to keep it quiet. If the sample were split into thirds and each of two of the parts tested by an independent organization then if the results agreed one would have high confidence that the results were accurate, and if they disagreed then the third sample could be tested and there would be a high confidence level if it matched one of the first two results that that result was the correct one. (This is 3-way redundancy and typically done where there is a high risk to safety.)
(See, I already made a mistake; I meant to include Kay in the congratulations.)
Is it that difficult to write an accurate headline?
Inadequate monitoring . . . which should have found the "unsanitary practices" at the pharmacy has resulted in illnesses and death for individuals seeking relief from chronic pain.
I see that the common practice is to have A/C on all the time in "sterile labs" to maintain temp and humidity levels. I am wondering if there are specifics for the quality of injected air and for air pressure internal to the room. Positive air pressure in the room would help to prevent infiltration of air-borne contaminants, and air filtration (perhaps HEPA?) would remove contaminants. I believe that is the norm in the computer chip industry. In infer (from reading this article) that these "sterile labs" are not really sterile, but that testing is used to detect problems which might be too big for the autoclav process to rectify. Sterilization would be guaranteed by the autoclav process but it sounds like these autoclavs were not up to the necessary spec. Or can an autoclav only handle a certain degree of contamination? If the autoclavs weren't good enough then that should have been caught early on by inspectors. After all, if the "sterile lab" is not really expected to be sterile then the autoclav is the last (and almost only) line of defense. Did inspectors check the autoclav models and serial numbers?
This comment has been removed.