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The FDA recently issued a Warning Letter to a contract manufacturer that is not the marketer of the product. I think it's of interest for this thread.
My perception of the warning letter is that it was issued because a significant part of the shortfall was in regard to sterile barrier packaging followed by sterilization. These of course are activities that are highly regulated.
The FDA clearly denoted the contract manufacturer as such, but then described them as a finished product manufacturer. Under the existing guidances, it's not apparent that a company can be both at once. If the "finished product" characterization is because the contract manufacturer is conducting sterile barrier packaging and sterilization, one wonders what the implications are for contract service providers that specifically provide these two services, but do nothing else. Are they the device maker, even if they had nothing to do with making the device itself?
I think this instance makes clear that whatever the FDA provides as general guidance regarding outsourcing and contract/component manufacturing and services, they are willing to override that guidance when they believe its requirements would not be adequate to control an outside vendor's procedural shortcomings that negatively affect medical device safety and effectiveness.
My perception of the warning letter is that it was issued because a significant part of the shortfall was in regard to sterile barrier packaging followed by sterilization. These of course are activities that are highly regulated.
The FDA clearly denoted the contract manufacturer as such, but then described them as a finished product manufacturer. Under the existing guidances, it's not apparent that a company can be both at once. If the "finished product" characterization is because the contract manufacturer is conducting sterile barrier packaging and sterilization, one wonders what the implications are for contract service providers that specifically provide these two services, but do nothing else. Are they the device maker, even if they had nothing to do with making the device itself?
I think this instance makes clear that whatever the FDA provides as general guidance regarding outsourcing and contract/component manufacturing and services, they are willing to override that guidance when they believe its requirements would not be adequate to control an outside vendor's procedural shortcomings that negatively affect medical device safety and effectiveness.
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