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> The strict FDA requirements are there to make sure only safe and effective products come onto the market How did this product fail then?
by Chris2048 9y ago
> The strict FDA requirements are there to make sure only safe and effective products come onto the market
How did this product fail then?
- Clubber 9y agoI would guess because once approved, the FDA has a much more limited role. I believe they can force a recall though. Technically the problem was mechanical, not pharmaceutical. I'm not sure if that had anything to do with it though.
- ska 9y agoThe letter is not about the drug. It's about the drug delivery device (i.e. the "pen"), and the failure of Pfizer/Meridian (the contract manufacturer of the device) to follow correct design and manufacturing practices. They don't have a proper CAPA system in place, they don't have proper design control or procedures, the DHFs are missing up to date inputs, risk analysis isn't up to date, etc. It's pretty damning, but it's not about the pharma aspect of this. Basically the manufacturer lacks a functional quality system, which is table stakes for this stuff.