Okay, so you run a company called Advanced Sterilization Products. Given that name, what’s the minimum you need to do? You need to have products, obviously, and they must relate to sterilization. Anything else? Well, they should be advanced. Now of course, that’s a somewhat subjective term, so there’s probably some room for disagreement between you and those bureaucrats at the FDA. What’s advanced? What’s not advanced? You don’t want to be misleading, and one might expect some dispute over the term.
The U.S. Food and Drug Administration has reached a $1.25 million settlement of a civil money penalty action against Advanced Sterilization Products (ASP) and two of ASP’s executives alleging that ASP manufactured and distributed…misbranded sterilization monitoring products.
A million bucks for arguing over the word “advanced”? But that’s a qualitative term! Who knows what’s “advanced”? Reasonable people can differ!
Argh, those bureaucrats, wasting everyone’s time with semantic games, dragging a good company through the mud… Wait, what?
We’re not arguing about “advanced”?
This is about sterilization???
Let’s fill in the blanks:
The U.S. Food and Drug Administration has reached a $1.25 million settlement of a civil money penalty action against Advanced Sterilization Products (ASP)… and two of ASP’s executives alleging that ASP manufactured and distributed adulterated and misbranded sterilization monitoring products.
Adulterated and misbranded? That’s a different story.
This action was taken after the FDA learned that the company knew that it did not have sufficient data to support the shelf life stated on the label of its Sterrad Cyclesure 24 Biological Indicators, but continued to ship the product to customers with inaccurate expiration dates. Sterrad Cyclesure 24 Biological Indicators are used to monitor and confirm the effectiveness of the sterilization process in ASP’s Sterrad sterilizers.
Sheesh. How can you run a company called Advanced Sterilization Products and put something on the shelf that cannot guarantee sterilization? Who’s running the place – this guy?
Martins: Have you ever seen any of your victims?
Harry Lime: You know, I never feel comfortable on these sort of things. Victims? Don’t be melodramatic. Look down there. Tell me. Would you really feel any pity if one of those dots stopped moving forever? If I offered you twenty thousand pounds for every dot that stopped, would you really, old man, tell me to keep my money, or would you calculate how many dots you could afford to spare? Free of income tax, old man. Free of income tax – the only way you can save money nowadays.
Sometimes it’s hard to figure out your company’s mission. And sometimes it’s right there in your freaking name. Follow your name, Advanced Sterilization Products! And stop cheating America!
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