Well again this comes down to management - or more accurately lack of management.
It absolutely SOP to have audits of all your suppliers done on these types of products - hell this SOP for all cosmetic products.
There are dozens of reputable firms that do independent audits of supplier sites. As the saying goes measure twice - cut once.
You never want this kind of thing to happen with the FDA - because it sets a very bad precedent. They will look at it as not just one item, but because you missed something so basic that there potentially other problems that just haven't popped up yet.
Zerbe tried to blame the supplier yesterday and said quote - 'the supplier has to get their act together'. No IGXT has to learn how to run a real business and not just a laboratory.
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